Worldwide Distribution - US including FL, CA  Foreign: Austrailia, New Zealand, France, Brazil
Sesamoid Plasty, Stereotaxic Instrument  The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation systems. The affected Sesamoid Plasty components are the central structural column and its base that hold up the computer and the tracking camera on the Sesamoid Plasty workstation. They are also designed to be disassembled such that the column can be folded onto itself for ease of transport after use. This is a retrospective recall report for a removal initiated on 17 June 2008
Zimmer CAS voluntarily conducted a retrospective recall of the  Sesamoid Plasty due to the risk of the top of the workstation to potentially fall over during disassembly.
Nationwide Distribution to:  AZ  CA  IA  IL  IN  LA  MA  MD  ME  MI  MN  PA  VA
DePuy Synthes   various orthopedic instruments modified by U.S. Distributors  These instruments are used in various orthopedic procedures
Products were made outside of Quality System Regulation, and potentially outside of premarket submission (510k/PMA) for certain devices.  The safety or effectiveness of these devices cannot be assured.
Nationwide Distribution and Internationally to Canada and  Malaysia
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short.  1 Unit. Sterile. Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Connection issues between the PD transfer set catheter connector and an adapter may lead to leaks and contamination of the fluid pathway which may  result in peritonitis.
Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapuetic devices into the vasculature.
unknown-firm reports total devices distributed 43,394
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
Arrow PICC with Chlorag+ard Technology  The ArrowEVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring
antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous access including, but not limited to the following: multiple infusions of fluids, medications, or chemotherapy; infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values; frequent blood sampling or blodd/blood component infusions; infusion of incompatible medications; central venous pressure monitoring; lack of usable peripheral IV sites; replacement of multiple peripheral sites for IV access
ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit  The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard(R) technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard(R) antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
unknown-firm reports total devices distributed 43,394 eaches
ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit  The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration
Arrow Pressure Injectable PICC Kit  The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling
510K # K061289; Material numbers: EU-04041-HPMSB, EU-04052-HPMSB, EU-05041-HPMSB, and EU-05052-HPMSB.
Arrow Pressure Injectable PICC Kit  The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit.  The Arrow(r) CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy, infusions of fluids that are hypertonic, hyperosmolar, or have divergent pH values; frequent blood sampling or blood/blood component infusions; infusion of incompatible medications; central venous pressure monitoring; lack of usable peripheral IV sites; replacement of multiple peripheral sites for IV access
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter  The Arrow(r) CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy; infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values; frequent blood sampling or blood/blood component infusions; infusion of incompatible medications; central venous pressure monitoring; lack of usable peripheral IV sites; replacement of multiple peripheral sites for IV access
ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions  The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy; infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values; frequent blood sampling or blodd/blood component infusions; infusion of incompatible medications; central venous pressure monitoring; lack of usable peripheral IV sites; replacement of multiple peripheral sites for IV access
The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofiltration. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard Blue antimicrobial surface catheter helps provide protection against catheter-related infections resulting from microorganisms migrating the subcutaneous tract along the exterior surface of the catheter when used for infusion. Clinical data have not been collected that demonstrate the use of the ARROWg+ard Blue antimicrobial surface in decreasing catheterrelated infections in hemodialysis patients. The catheter is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions for High Volume Infusions  The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy; infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values; frequent blood sampling or blodd/blood component infusions; infusion of incompatible medications; central venous pressure monitoring; lack of usable peripheral IV sites; replacement of multiple peripheral sites for IV access
Pressure injectable Jugular Axillo-Subclavian Central CThe CG+Arrow JACC powered by Arrow VPS Stylet permits venous access to the central circulation through a central veinatheter (JACC) Product
Arrow PICC with Chlorag+ard Technology  A PICC permits venous access to the central circulation through a peripheral vein. The intended use of the VP'S Stylet and Console (VPS System) is to quickly and accurately guide market available central catheters to the desired location which is the lower third of the SVC or at the cavo-atrial junction
The CG+ Arrow JACC powered by Arrow VPS Stylet permits venous access to the central circulation through a central vein. The VPS Stylet, used with the VPS Console, quickly and accurately guides the central catheters to the desired location which is the lower third of the SVC or at the cavo-atrial junction
AGB+ Pressure Injectable Multi-Lumen CVC Kit  intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins  intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins
Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology    The ArrowEVOLUTIONTM Pressure Injectable P1CC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the An-owEVOLUTIONTM Pressure Injectable P1CC may not exceed 300 psi. Chlorag+ard Technology treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization and thrombus accumulation on catheter surfaces. Antimicrobial and antithrombogenic effectiveness were evaluated using in vitro and in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections or vein thrombosis
Two-Lumen Hemodialysis Catheterization Kit with Blue Flex Tip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions for High Volume Infusions.  The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard(R) technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard(R) antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapuetic devices into the vasculature
MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 -8 Fr. Catheters.  The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard(R) technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard(R) antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
Arrow PICC with Chlorag+ard Technology  A PICC permits venous access to the central circulation through a peripheral vein
ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit.  The MAC Two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation
unknown-firm reports total devices distributed 43,394 each
Arrow Pressure Injectable PICC Kit    The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit    The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It may be inserted into the jugular, subclavian, or femoral veins
Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter  The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which is to the cavo-atrial junction near the sino-atrial node
ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit.  The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It ma be inserted into the jugular, subclavian or femoral veins
Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostatis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5-8 Fr. Catheters.  The Arrow Percutaneous Sheath Introducer permits venous access and catheter introduction to the central circulation. The ARROWg+ard antimicrobial surface is intended to help provide protection against sheath-related infections. The sheath is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use
Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology  The ArrowEVOLUTIONTM Pressure injectable P1CC with chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring
ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit  The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy; infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values; frequent blood sampling or blodd/blood component infusions; infusion of incompatible medications; central venous pressure monitoring; lack of usable peripheral IV sites; replacement of multiple peripheral sites for IV access
MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters  The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard(R) technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard(R) antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
510K # K002507; Material number: ASK-21142-HF2
ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters  The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard(R) technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard(R) antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
Arrow(R) VPS(R) Access Kit for use with 5 Fr. Peripherally Inserted Central Venous Catheter      The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which is to the cavo-atrial junction near the sino-atrial node
Arrow VPS Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally inserted Central Venous Catheter  The Arrow(r) CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy; infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values; frequent blood sampling or blood/blood component infusions; infusion of incompatible medications; central venous pressure monitoring; lack of usable peripheral IV sites; replacement of multiple peripheral sites for IV access.
1 0 control vials per box, 12 cell foam insert.    Product Usage:  MedTest DX Controls Level 1 and 2 is lyophilized human based control sera for use in the quality control of diagnostic assays. Human sera can be supplied as an assayed serum for control of accuracy or as a precision serum for control reproductivity. Concentration are available in 2 levels, normal (HNC) and elevated (HEC).
MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200)  and Level 2 (HEC200) control values are outside of specification.
Estradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-022-01
CGMP deviations- Lack of Quality Assurance
Estradiol 6 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by; Qualgen 14844 Bristol Park Blvd. Edmond, OK 73013 NDC: 69761-006-01.
Estradiol 10 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only , For Subcutaneous Use Only Rx Only Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-010-01
Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, NDC: 69761-012-01
Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-020-01
Estradiol 15 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles. Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, NDC: 69761-015-01
Estradiol 25 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles,  Sterile Office Use Only, For Subcutaneous Use Only. Rx Only ,Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-025-01,
Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid  NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-018-01.
US: CA  CO  CT  DC  DE  FL  IA  ID  IL  MA  MD  MI  MO  NC  NJ  NV  NY  OH  OR  PA  RI  SC  TX  VA
C. botulinum hazard in vacuum packaged pizza crust.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
White Wheat Bread and White Wheat Texas Toast all units 24 oz per bag
HEB Texas Toast UPC 4122062888 and HEB X-Thin UPC 4122084868  all units 24 oz per bag
Hill Country Fare Thin Sandwich UPC 4122046090; Hill Country Fare Extra Thin Sandwich UPC 4122063420; Good Thin Bread; Good Bread Texas Toast; Clear Prison This; Clear Prison X-Thin all units 24 oz per bag
Hill Country Fare Wheat Sandwich UPC 4122078985; Good Bread Wheat UPC 4122018146; Clear Bag Wheat; all units 24 oz per bag
HEB White RT  UPC 4122035774 and HEB ST White UPC 4122088001 all units 24 oz per bag
Acyclovir Tablets, USP, 800 mg, 100-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, by Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-778-01
Presence of Foreign Substance:  human hair melded into tablet.
KRISPPE FAMOUS RHODE ISLAND CLAM CAKE MIX NET WEIGHT 5 lbs., 25 lbs., 50 lbs.
KRISPPE BATTER MIX For FISH & CHIPS Net WEIGHT 5 lbs., 25 lbs., 50 lbs.
KRISPPE CLAM-FRY-MIX NET WEIGHT 5 lbs., 25 lbs., 50 lbs.
Worldwide Distribution - US (nationwide) and countries of: Australia, Austria, Belgium, Bahrain, Canada, China, Costa Rica, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Lithuania, Latvia, Malaysia, Netherlands, Romania, Russia, Saudi Arabia, Singapore, Spain, Switzerland, United Arab Emirates, and United Kingdom.
LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open packages.    Used to aid in the introduction of a LapSac during endoscopic surgical procedures.
COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
CATALOG NUMBER: and GPN: J-LSI-102500 & G16500  Dates of Manufacture: February 2012 to December 2016
Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages.    Used for internal suturing under direct vision during intraabdominal endoscopic procedures. The needle driver design affords precise placement and control of standard curved suture needles, similar to open abdominal suturing.
CATALOG NUMBER: and GPN: J-ENH-033100 & G16426,  J-ENH-053100 & G16427, J-ENH-053120 & G16428,   J-ENH-053130 & G16429  Dates of Manufacture: January 2012 to February 2017
Willscher Vas Reapproximator Plate, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages.    Used to stabilize the vas ends during microscopic vasovasostomy.
CATALOG NUMBER: 092002 and 096511, GPN: G15612 and G15573, The device was obsoleted on 04/30/2008
Willscher Vas Skewers, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages.    Used to stabilize the vas ends during microscopic vasovasostomy.
CATALOG NUMBER: 092001, GPN: G14512, The device was obsoleted on 04/30/2008
Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages.    Used to stabilize the vas ends during microscopic vasovasostomy.
CATALOG NUMBER: 092000, GPN: G14500, Dates of Manufacture: January 2012 to March 2016,
LapSac Introducer Set, Bag, Extraction, Supplied sterilized by ethylene oxide gas in peel-open packages.    Used to aid in the introduction of a LapSac during endoscopic surgical procedures.
CATALOG NUMBER and GPN: 054300 & G15771  Dates of Manufacture: January 2012 to August 2015
Ellex Tango Reflex  with slit lamp Laser Ophthalmic    In the SLT mode, the device is intended to be used for selective laser trabeculoplasty (ST) operations (laser trabeculoplasty for primary open angle glaucoma). In the VAG mode it is intended to be used to perform procedures requiring the rupture of tissue in the eye for Iridotomy and Iridectomy, Posterior capsulotomy and Posterior membranectomy.
It was discovered the unit produced a laser emission without pressing the fire button when the slit-lamp  was driven to its lowest  position prior to use on any patient.
SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE.    Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients.
feature to ensure monitor alarms are transmitted to compatible nurse call systems.
AUNT JEMIMA(R) 14 HOMESTYLE WAFFLES, NET WT 17.18oz UPC 019600062004
Potential for Listeria monocytogenes contamination
AUNT JEMIMA(R) MiNi pancakes, MAPLE BLAST, NET WT 3.2 OZ, UPC 001960043563
AUNT JEMIMA(R) 12 PANCAKES MADE WITH WHOLE GRAIN, NET WT 14.5oz UPC 019600066408
AUNT JEMIMA(R) 12 BUTTERMILK PANCAKES, NET WT 14.8oz UPC 019600068204
Aunt Jemima(R) Cinnamon Swirl French Toast, 144 COUNT, NET WT 13.5 LBS, UPC001960005880
AUNT JEMIMA(R) CINNAMON FRENCH TOAST, 6 COUNT, NET WT 12.5oz, UPC 019600058908
Mrs. Butter-worth's(R) ORIGINAL PANCAKES, 144 COUNT, NET WT 10.6 LBS, UPC 001960046004
AUNT JEMIMA(R) HOMESTYLE FRENCH TOAST, 6 COUNT, NET WT 12.5oz, UPC 019600057703
Aunt Jemima(R) Thick French toast, 72 COUNT, NET WT 10.7 LBS, UPC 001960043560
Aunt Jemima(R) Original Thin French toast, 144 COUNT, NET WT 13.5 LBS, UPC 001960005870
AUNT JEMIMA(R) 12 OATMEAL PANCAKES, NET WT 14.8oz UPC 019600064909
Hilltop HEARTH WAFFLES, 18 BOLSAS CON 8 PIEZAS, PESO NETO 11LB 6.4 oz, UPC075810843855
AUNT JEMIMA(R) BUTTERMILK 12 LOW FAT PANCAKES, NET WT14.5oz UPC 019600061007
AUNT JEMIMA(R) LIL' GRiDDLES(TM) MINI pancakes, 40 COUNT, NET WT 14.5oz UPC 019600054801
AUNT JEMIMA(R)  FRENCH TOAST MADE WITH WHOLE GRAIN, 6 COUNT, NET WT 12.5oz, UPC 019600059684; Aunt Jemima(R) French toast made with Whole Grain, 72 COUNT, NET WT 11.25 LBS, UPC 001960043583
Homestyle pancakes packaged as follows:    a) AUNT JEMIMA(R) 12 HOMESTYLE PANCAKES, NET WT 14.8oz UPC 019600069102  b) AUNT JEMIMA(R) HOMESTYLE PANCAKES, 60 COUNT, NET WT 4.63 LBS, UPC 019600435907  c) AUNT JEMIMA(R) HOMESTYLE PANCAKES,60 COUNT   (MEXICO), NET WT 4.29 LBS, UPC 019600435921  d) AUNT JEMIMA(R) HOMESTYLE PANCAKES, 60 COUNT, NET WT 4.29 LBS, UPC 001960043596
Aunt Jemima(R) Cinnamon Swirl Thick French Toast, 144 COUNT, NET WT 10.7 LBS, UPC 001960043584
AUNT JEMIMA(R) 14 BUTTERMILK WAFFLES, NET WT 17.18oz UPC 019600062103
AUNT JEMIMA(R) 14 BLUEBERRY WAFFLES, NET WT 17.18oz UPC 019600062202
Aunt Jemima(R) Whole Grain Mini Pancakes, 12-40 COUNT, NET WT 12 LBS, UPC 001960043558
AUNT JEMIMA(R) 12 BLUEBERRY PANCAKES, NET WT 14.8oz UPC 019600064701
Waffles packaged as follows:  a) Aunt Jemima(R) Waffles, 144 COUNT, NET WT 7.88 LBS, UPC 001960043575  b) Aunt Jemima(R) Jumbo Square Waffles, 144 COUNT, NET WT 11.4 LBS, UPC 001960043573  c) Aunt Jemima(R) Waffles, 144 COUNT, NET WT 7.88 LBS, UPC 001960043575  d)  Mrs. Butter-worth's(R) WAFFLES, 72 COUNT, NET WT 7.88 LBS, UPC 001960046009  e) Mrs. Butter-worth's(R) WAFFLES, 144 COUNT, NET WT 11.4 LBS, UPC 001960046001  f) Hilltop HEARTH WAFFLES, 18 BOLSAS CON 8 PIEZAS, PESO NETO 11 LBS 6.9 OZ, UPC 075810861817  g) Aunt Jemima(R) Original Round Waffles, 144 COUNT, NET WT 11.25 LBS, UPC 001960043580
AUNT JEMIMA(R) MiNi pancakes, CINNAMON ROLL, NET WT 3.2 OZ, UPC 001960043568
AUNT JEMIMA(R) LIL' GRIDDLES(TM) BLUEBERRY MINI PANCAKES, 40 COUNT, NET WT 14.5oz UPC 019600054603
AUNT JEMIMA(R) MiNi pancakes, BLUEBERRY BLAST, NET WT 3.2 OZ, UPC 001960043567
AUNT JEMIMA(R) 14 LOW FAT WAFFLES, NET WT 17.18oz UPC 019600062301
French toast packaged as follows:  a) Hilltop HEARTH, FRENCH TOAST, 18 8 COUNT BAGS, NET WT 10 LB 11.2 OZ, UPC 075810861816  b) Hilltop HEARTH, FRENCH TOAST, 12 6 COUNT BAGS, NET WT 10 LB 11.2 OZ, UPC 075810843855  c) Hilltop HEARTH FRENCH TOAST, 12 6 COUNT BAGS, NET WT. 10 LB 11.2 OZ, UPC 075810843854  d) Mrs. Butter-worth's(R), FRENCH TOAST, 144 count, NET WT. 13.5, UPC 001960046003
Worldwide Distribution - US to GA only, Foreign: Europe
NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1.  The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.
Software defect: the NBS software may accidentally generate duplicate copies of one or several files.
Nexstim eXima NBS System Software version 2.2 or higher.  The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.
Serial numbers: NBS101, NBS106, NBS140, NBS141, NBS145, NBS148, NBS155, NBS159, NBS163, NBS164, NBS166.  NBS158 has been scrapped.
Worldwide Distribution - US (Nationwide)  Foreign:  AUSTRALIA  AUSTRIA  BOLIVIA  CANADA  CHILE  CHINA  COLOMBIA  DOMINICAN REPUB  ENGLAND  GERMANY  INDIA  UK  ISRAEL  ITALY  JAPAN  KOREA  MALI  MYANMAR  SPAIN  NEPAL  NETHERLANDS  NEW ZEALAND  P.R. CHINA  PANAMA  US  PERU  PHILLIPINES  POLAND  PORTUGAL  REP OF KOSOVO  SOUTH AFRICA  SRI LANKA  USA  SWEDEN  SWITZERLAND  TRINIDAD  UNITED ARAB EMI  VIETNAM
Magellan Diagnostics LeadCare and LeadCare II test Kits.     Product Usage:  The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and Treatment Reagent of the Test Kit are specific for lead only. Contents of this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.
Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems
Magellan Diagnostics LeadCare Ultra and LeadCare Plus  test Kits.   Product Usage:  The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and Treatment Reagent of the Test Kit are specific for lead only. Contents of this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.
Product was sent to one manufacturer in MI
Honey Bourbon Pecans Net Wt. 20 lb. (9.088g) Mfg. By: Trophy Nut Co. Tipp City, OH 45371
The firm stated that the product contains undeclared allergens.
cake product is recalled due to undeclared soy lecithin.  The canola spray oil containing soy lecithin was used but soy or soy lecithin is not declared on label.
Worldwide Distribution - US Nationwide in the states of (TX, AL, UT, FL, IA, SD, NV, OH, CA, MN, CO, AZ, OK, MI, VA, KY, and Puerto Rico) and country of Japan
Arsenal Spinal Fixation System, Set Screw, Part No. 47027      Product Usage:  The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and bridges that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and bridges are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELl). The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (CP Ti Grade 4, Ti-6AI-4V ELl, and Co-28Cr-6Mo).
Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw  postoperative disengagement from the screw body.
Moose Tracks Cheesecake, Net Wt. 18 oz (510g).  Black plastic base with clear plastic dome.  Back label includes nutrition labeling for Pumpkin Swirl Cheesecake.  Manufactured by The Father's Table, LLC
Cheesecake has incorrect rear label.  The rear label is for Pumpkin Swirl Cheesecake which lacks peanut allergen declaration.
Pick 5 Chicken & Waffle Sandwich; Mix & Match, Keep Frozen; Net Wt. 14.4 oz.; Distributed by:  Save-A-Lot Food Stores, Ltd., Earth City, MO 63045; UPC: 051933353664
Product has the potential to be contaminated with Listeria monocytogenes.
CA, CT, FL, IL, IN, MD, MI, MN, MO, MS, NC, NJ, NY, NV, OH, PA, TX, VA, WI and WV.
Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,
Cobas connection module (CCM) - OUTPUT UNIT  The module CCM enables a unidirectional connection of the pre-analytical systems cobas p 612/ p 512 to analysis instruments from Roche Diagnostics, Hitachi or Sysmex by means of the Aloka transportation system
a gap between the conveyor belt and the rack tray table (plastic part) may cause vibration of the 5 position racks during the transport. This issue can pose a  potential risk to involved operators and can also lead to potential cross contamination  of samples in the affected racks.
Nationwide, military/VA/govt and foreign consignee (No Canadian consignees)
Berchtold Chromophare F300 Exam Light  CHROMOPHARE examination lights are medical lights used for local illumination of the patients' body so that illnesses, injuries and disabilities can be diagnosed and treated
The exam light may have a tolerance issue with the adapter assembly, which could potentially not allow the snap ring to be seated correctly.  If this is the case, there could be insufficient mount force that may cause the equipment to fall, resulting in serious injury.
Honest Wipes, 10 count packages, 72 count packages, 288 count packages, and 576 count packages.    -10ct: 48 units per case or 24 units per case  - 72ct: 12 units per case  - 288ct: 3 units per case  - 576ct: 8 units per case
The Honest Company is recalling Honest Wipes due to the possible presence of mold.
distributed in AR, AZ, CA, CO, IL, KS, KY, MN, MO, NE, NM, NV, OK, OR, TN, TX, UT, WA, and WY.
Red Robin Burgers and Brews Crispy Onion Rings, frozen, Net wt. 14 ounce.  Retail package UPC 0 43301 61119 3.
Red Robin Burgers and Brews Crispy Onion Rings, 14 oz. retail packages, are recalled due to undeclared milk.
Worldwide Distribution-US distribution to: MO, NY, KY, FL, NC and OH; and countries of:  AUSTRALIA, FRANCE and SPAIN.
Response BandLoc 5.5/6.0 Tensioner Instrument    The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon to apply a recommended tension to the band and hold it in place during spine manipulation and set screw tightening.
Over-tensioning of the band resulting in damage to the band  causing it to rupture
Worldwide Distribution - US Nationwide in the countries of Belgium, Canada, Japan, Netherlands
Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G AMC/4; Clear Flashback Needle 7 cm x 19G AMC/4    Usage:  Argon Arterial Access Needles are designed to provide vascular access for the percutaneous introduction of a guidewire.
Argon Medical has received a complaint from one of their distributors of a potential packaging defect.  The product is sealed in a pouch and the defect if present shows as a potential void or unsealed edge of the pouch.
Worldwide Distribution - US to AZ; Internationally to ECUADOR; CANADA; UK; BRAZIL
Urea Base Agar, Acumedia PN 7226  Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production
CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom,  and Vietnam
Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FITS-All Conn., Product Code 3104-E
Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector, Product Code 3224-E and Product Code 3226-E
Non-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3108-E, Product Code 3108MM, Product Code 86-106E, Product Code 86-108-E, Product Code LM-86-106, Product Code PMD06002, Product Code PMD06003
Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m (7) Oxygen Tubing, Product Code 106MM
Non-Rebreather Oxygen Mask, Pediatric with Tubing, Product Code 86-3226E, Product Code PMD06009, Product Code PMD06106
Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, One Side Valve, Product Code 3230-E
Non-Rebreathing Mask, Reservoir Bag, Check Valve, Two Side Valves, with Tubing, Product Code 3230MM
Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, Two Side Valves, Product Code 3266-E
Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing, Product Code 106-E,  Product Code 3226MM, and Product Code 9108MM
Non-Rebreather Mask, Reservoir Bag, Check Valve, Two Side Valves, No Tubing, Product Code 226MM
Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7) Oxygen Tubing, Product Code 108MM
Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;
Reports of tubing detaching from oxygen masks either prior to use (in packaging) or during use were made by different end users and for different batches. The failures were caused by an improper solvent bond between the oxygen tubing and the oxygen mask connector. While the defect affects less than 2% of recalled product, there is a potential for harm when oxygen supply to the user is disrupted.
Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, One Side Valve, FITS-All Conn., Product Code 3106-E
Rebreathing Mask, Reservoir bag, with Tubing, Product Code 104MM
Oxygen Masks, Elongated (Under Chin), Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, Two Side Valve, Product Code 108-E
Pediatric, High Conc. Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-ALL Oxygen Connector 50 Check Valve, One Side Valve, Product Code 9226-E
Red Blood Cells, not meeting product quality control specifications, were distributed.
Oatmeal Chocolate Chip Cookies, 18pk, NET WT. 0 lb 10 oz (283 g), Dist. by Whole Foods Market, 1105 N. Lamar, Austin, TX  78703 USPC 0247181 004992
undeclared walnuts in Oatmeal Chocolate Chip cookies
UPC beginning with 0247181, Sell By 05.19.17
Worldwide Distribution - USA (nationwide) and to the countries of : Argentina, Australia, Austria, Canada, Cyprus, France, Germany,  Hong Kong, Ireland, Islamic Republic of, Israel, Italy, Japan, Kingdom of Saudi Arabia, Kuwait, New Zealand, People's Republic of China, Philippines, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, R.O.C., and United Kingdom.
Large Stealth Chamber, Catalog Numbers:  DS50-001-XL-T,  DS50-002-XL-T,  DS50-003-XL-T,  DS50-102-XL-T, DS50-103-XL-T
When the Stealth Chamber is used as a reference detector in relative dosimetry, deviation in the measured PDDs at shallow depths and geometric shadowing of measured profiles may appear.
All customers are within the United States.
High Liner Foods, Lightly Breaded Cod Portions 8oz.
The firm has decided to recall various products due to undeclared milk.
High Liner Foods, Lightly Breaded Cod Tail Portions 4 oz. and 5 oz
FPI, Crunchy Lites Raw Breaded Alaska Pollock Portions 3.6 oz
Viking, Breaded Natural Flounder Fillets 4 oz.
A&W, GIN 0040995 Raw Breaded Fish Portions 3.5 oz
High Liner Foods, Breaded Haddock Tail Portions 5 oz.
Frozen Yellowfin tuna cubes, random;  Individually vacuum packed;    15 lb. case.    Product of the Philippines;  Brand - Krimson Product;  UPC  10664183002946  Ingredient: - Frozen Tuna and tasteless smoke - to promote color retention.    Imported by Hilo Fish Company Inc., Honolulu, HI.
199 cases , 15 x 1 lb. packages per case.
Independent lab testing found positive results for Hepatitis A in tuna products.
Production date code: 705342,   Lot number: 173448; Expiration dates: 2019-04-01
Tuna Steaks, 8 oz.  individually vacuum packed bags;  Krimson Brand, Product of Vietnam;  10 lb. cases;  Ingredients: frozen tuna and tasteless smoke to promote color retention.  UPC: 10664183000751
Production date code: 627152,   Lot number: 166623; Expiration date: 2018-10-01
Apheresis Platelets, Leukocytes Reduced, Irradiated
Apheresis product, in which residual WBC count was not performed, was distributed.
Blood product, in which residual WBC count was not performed, was distributed.
Apheresis unit, incorrectly labeled as Leukocytes Reduced was distributed.
KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-135-81
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-136-81
Zenatane (isotretinoin) Capsules, USP, 40 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-137-81
Zenatane (isotretinoin) Capsules, USP, 30 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-113-81
Ravioli Butternut. Product is made refrigerated.    Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some containers have Alaska Pasta written on them.      Product is not packaged for retail and weights vary depending on orders.
Undeclared soy lecithin. The firm used Canola oil cooking spray, which contains soy lecithin, in the manufacture of product but soy or soy lecithin is not declared on finished product label.
No lot codes.  The date of production is marked on the side of the plastic container.
Linguine. Product is made refrigerated.    Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some containers have Alaska Pasta written on them.      Product is not packaged for retail and weights vary depending on orders.
Penne. Product is made refrigerated.    Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some containers have Alaska Pasta written on them.      Product is not packaged for retail and weights vary depending on orders.
Ravioli  Mushroom. Product is made refrigerated.    Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some containers have Alaska Pasta written on them.      Product is not packaged for retail and weights vary depending on orders.
Lasagne Sheets. Product is made refrigerated.    Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some containers have Alaska Pasta written on them.      Product is not packaged for retail and weights vary depending on orders.
Riggatoni. Product is made refrigerated.    Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some containers have Alaska Pasta written on them.      Product is not packaged for retail and weights vary depending on orders.
Shells. Product is made refrigerated.    Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some containers have Alaska Pasta written on them.      Product is not packaged for retail and weights vary depending on orders.
Fettuccine.  Product is made refrigerated.    Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some containers have Alaska Pasta written on them.      Product is not packaged for retail and weights vary depending on orders.
Undeclared soy lecithin. The firm used Canola oil cooking spray, which contains soy lecithin, in  the manufacture of product but soy or soy lecithin is not declared on finished product label.
Ravioli  Lobster. Product is made refrigerated.    Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some containers have Alaska Pasta written on them.      Product is not packaged for retail and weights vary depending on orders.
Ravioli Cheese. Product is frozen.    Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some containers have Alaska Pasta written on them.      Product is not packaged for retail and weights vary depending on orders.
Lasagne Sheets Spinach. Product is made refrigerated.    Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some containers have Alaska Pasta written on them.      Product is not packaged for retail and weights vary depending on orders.
Gemelli. Product is made refrigerated.    Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some containers have Alaska Pasta written on them.      Product is not packaged for retail and weights vary depending on orders.
Ravioli Spinach. Product is made refrigerated.    Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some containers have Alaska Pasta written on them.      Product is not packaged for retail and weights vary depending on orders.
Ravioli  Orso. Product is made refrigerated.    Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some containers have Alaska Pasta written on them.     Product is not packaged for retail and weights vary depending on orders.
Fettuccine Gluten Free. Product is made refrigerated.    Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some containers have Alaska Pasta written on them.      Product is not packaged for retail and weights vary depending on orders.
Spaghettoni. Product is made refrigerated.    Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some containers have Alaska Pasta written on them.      Product is not packaged for retail and weights vary depending on orders.
Red blood cell, for which the antigen labeling tag was incorrect , was distributed.
Plasma product, for which a donor screening deviation occurred, was distributed.
US distribution only.  KS, MD, PA, CA, WA, MO, NC, SC, ME, NY, CO, OH, KY, TN, VA, IN, GA, OR, AZ,UT, WI, TX, MA.
California  Sun Dry Sun Dried Tomato Pesto;  NET WT. 8.5 oz. (241g) glass jar;    Ingredients (incorrect) Garlic, Canola oil, sundried tomatoes (preserved with sulfating agents)  water, sola oil, spices, onion, salt, citric acid,, soy lecithin. Partially processed with Genetic Engineering.    UPC 7 38203 10911 3    California Sun Dry Foods, Danville, California.  Product of the USA.
2868 cases (6 jars per case of 17,208 individual units)
Firm employee noticed that incorrect back label was attached to Sun-Dried Tomato Pesto and therefore did not declare the allergens of almonds and milk..
Option 2, Levonorgestrel Tablet, 1.5 mg, Emergency Contraceptive, 1 Tablet per box, Distributed By Perrigo, Allegan, MI 49010. NDC 0113-2003-12
Defective Container: Carton is missing the tablet blister strip  and tablet.
Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Plant Base, Micronized, U.S.P active pharmaceutical ingredient, packaged in 1g, 5g, 25g, 6 x 25g, and 100g containers, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA  90248, New Brunswick, NJ  08901, Product code E1435.
CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.
Levonorgestrel, U.S.P. active pharmaceutical ingredient, packaged in 1 kg container, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA  90248, New Brunswick, NJ  08901, Product code L1229.
methylcobalamin 1mg/1mL, vial for injection,  Rx only, MedPark Pharmacy 2002 Medical Pkwy. # 170 Annapolis, MD 21401