Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
The affected product was distributed in Ohio and Kentucky.
All poultry and swine animal feeds, medicated and non-medicated, which were manufactured using the contaminated lascadoil. The product is made and transported in bulk with no labeling.
Various animal feeds were manufactured using a contaminated oil as a raw material.
The firm does not assign lot or batch codes to product.
Smart Lipo Dietary Supplement capsules, 900 mg, packaged in 30-count plastic bottle,  Distributed by: SmartLipo365, Arlington, TX 76011
Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.
Smart Lipo Dietary Supplement capsules, 800 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011
Lucy's Weight Loss (dba. Waisted With Lucy)
Shorts on The Beach Golden Edition by Pink Bikini, 800 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.
Shorts on The Beach Strong Formula by Pink Bikini capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010
Pink Bikini Strong Formula capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010
Distributed in the states of CA, KY, MD, GA, and  IL.
ABG-HM-1 Hummi Micro Draw Blood Transfer Device    Product Usage:  It is used for blood transfer and collection from Peripheral Arterial Line Catheters.
Y connector and the yellow cannula hub may not be sufficiently secure enough and could separate while in use.
Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0025-5833-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5833-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ  08807 A Sanofi Company
Defective Delivery System; potential to have inaccurate dosage delivery
Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0024-5831-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5831-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ  08807 A Sanofi Company
LIPO ESCULTURA capsules, 250 mg, 60-count bottles, Distributed By: JAT Productos Naturales Corp., BROOKLYN, NY 11238, www.lipoesculturatreatment.com
Marketed Without An Approved NDA/ANDA: Tainted product marketed as a dietary supplement. Product found to be tainted with sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, and diclofenac, a prescription non-steroidal anti-inflammatory drug, making this an unapproved drug.
Shorts on the Beach capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured and Distributed by: Lucy's Weight Loss System (dba Waisted With Lucy), Arlington, TX 76010
Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac.
Pink Bikini capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured and Distributed by: Lucy's Weight Loss System (dba Waisted With Lucy), Arlington, TX 76010
The firm distributed the product to 132 domestic firms. Please see the attached spreadsheet for a list of all consignees.
CapriSun tropical punch packaged in a blue and white box with pictures of fruit and white and black lettering.
20, 298 cases, 4 boxes/case, 10 drinks/box.
Possible presence of glass fragments in CapriSun and Kool-Aid Jammers.
best when used by code date: 09 DEC 2016  GR02CT762
Kool-Aid Jammers Strawberry Kiwi packaged in a green and red box with white lettering.
best when used by code date: 09 DEC 2016 GR02CT762
Kool-Aid Jammers Cherry packaged in a red box with white lettering.
best when used by code date: 10 DEC 2016 GR02CT762 and 11 DEC 2016 Gr02CT762
CapriSun fruit punch roarin'waters packaged in a blue and white box with pictures of fruit and white lettering.
20, 298 cases, 4 boxes/case, 10 drinks/box
best when used by code date: 08 DEC 2016  GR02CT762 and 09 DEC 2016  GR02CT762
Kool-Aid Jammers Grape packaged in a purple and red box with white lettering.
best when used by code date: 10 DEC 2016 GR02CT762
Kool-Aid Jammers Tropical Punch packaged in a red blue and purple box with white lettering.
best when used by code date: 11 DEC 2016 Gr02CT762 and 12 DEC 2016 GR02CT762.
Black Ant, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules total), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Bull, packaged in CASE (10 packs / 3 capsules per can / 30 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Super Hard, packaged in BIG BOX (20 small boxes / 6 capsules per box / 120 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
African Black Ant, packaged in 8 small boxes / 6 capsules per box / 48 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Zhen Gong Fu, packaged in BIG BOX (16 small boxes / 2 capsules per box / 32 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Black Storm, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Hard Ten Days, packaged in BIG BOX (6 small boxes / 6 capsules per box / 36 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Man King, packaged in BIG BOX (8 small boxes / 5 capsules per box / 40 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Weekend Prince, packaged in 24 individual cards / 2 capsules per card/ 48 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Black Ant King, packaged in BIG BOX (10 capsules / can / 12 cans per box / 120 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Tiger King, packaged in BIG BOX (10 small bottles / 10 capsules per bottle / 100 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Plant Vigra, packaged in BIG BOX / (18 cans / 6 capsules per can / 108 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Happy Passengers, packaged in BIG BOX (30 small boxes / 1 capsule per box / 30 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Samurai-X, packaged in BIG BOX (24 individually wrapped capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Night Man, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Zhong Hua Niu Bian, packaged in BIG BOX (6 small boxes / 6 capsules per box / 36 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Germany Niubian, packaged in BIG BOX (10 small boxes / 24 capsules per box / 240 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Bigger Longer More Time More Sperms, packaged in BIG BOX (6 small boxes / 6 capsules per small box / 36 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Real Skill, packaged in 20 small boxes / 4 capsules per box / 80 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Bull's Genital, packaged in CASE (10 Cans / 10 capsules per can / 100 capsules),Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Stree Overlord, packaged in 10 small boxes / 1 capsule per box, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
African Superman, packaged in BIG BOX (6 small boxes / 8 capsules per box / 48 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Mojo Risen, packaged in BIG BOX (24 individual cards / 2 capsules per card/ 48 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Licorice Coughing Liquid (guaifenesin), 5%, 3.38 fl. oz. (100 ml), OTC, Manufactured by: Ma Ying Long Pharmaceutical Group Co., LTD, Wuhan, China; Distributed by: Master Herbs (USA) Inc., NDC 68511-0460-01
Marketed Without An Approved NDA/ANDA: presence of undeclared morphine.
0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL  60015, Product Code 2B0043, NDC 0338-0553-18.
Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.
Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA, Product Code 2B3421, NDC 0338-1055-48.
Presence of Particulate Matter: identified as a cloth fiber.
Presence of Particulate Matter: identified as cardboard.
CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection, 1000 mL Injection Port Chamber 30% Dextrose Injection with Calcium, 1000 mL Outlet Port Chamber 10% Amino Acid Injection with Electrolytes, 2000 mL CLARITY Dual Chamber Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL  60015, Product Code 2B7721, NDC 0338-1123-04.
Presence of Particulate Matter: identified as dried skin.
Nationwide via internet sales and directly via wholesalers located in CA, IN, FL, NY, PA, NV & WV
THE SAUSAGE MAKER SEASONING Trail Bologna under the following labels: 1) Net Wt 2 lbs. 8 oz, 2) Net Wt 25 lbs, 3) Trail Bologna Kit
227 total units (143 units/2lbs8oz, 3 units/25lbs, 84 units/kit)
Fermento ingredient contains undeclared whey protein and skim milk powder
THE SAUSAGE MAKER SEASONING Summer Sausage under the following labels: 1) Net Wt 8 oz, 2) Net Wt 2 lbs. 8 oz., 3 ) Net Wt 25 lbs, 4) Summer Sausage Kit
1,545 total units(1,220 units/2lbs8oz, 16 units/25lbs, 326 units/kit, 93 units/8oz)
THE SAUSAGE MAKER SEASONING Smoked Pepperoni under the following labels: 1) Net Wt 2 lbs, 2) Net Wt 25 lbs, 3) Smoked Pepperoni Kit w/Home Pak, 4) Smoked Pepperoni Salami Kit
462 total units (336 units/2lbs, 4 units/25lbs, 86 units/home pak, 72 units/kit)
THE SAUSAGE MAKER SEASONING Dried Sausage Sticks  under the following labels: 1) Net Wt 6.5 oz, 2) Net Wt 2 lbs, 3) Net Wt 25 lbs, 4) Dried Sausage Stick Kit, 5) Dried Sticks Assortment Kit
886 total units (39 units/6.5oz, 508 units/2lbs, 5 units/25lbs, 102 units/kit, 273 units/assortment kit)
THE SAUSAGE MAKER SEASONING Goetburg Summer Sausage under the following labels: 1) Net Wt: 2 lbs.8 oz, 2) Goteborg Summer Sausage Kit
82 total units (48 units/2lbs8oz & 35 units/kit, 20units)
THE SAUSAGE MAKER SEASONING Dried Sticks Hot under the following labels: 1) Net Wt 2 lbs, 2) Net Wt 25 lbs, 3) Hot Dried Sausage Sticks Kit w/19mm
256 units total (232 units/2lbs, 0 units/25lbs, 32units/kit
Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride,  Rx, total volume 1 mL, This is a compounded drug, CII, IV Use, syringe, Pharmakon Pharmaceuticals, NDC 45183-0322-78.
Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.
9 consignees - only 9 bottles distributed
SUPER HERBS 350 mg, 30 capsules per bottle.
Marketed without an approved NDA/ANDA - presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and/or phenolphthalein.
Product Codes: 6802220, 6802221; Affected Lot Numbers: 1410, 1420, 1430 (With Expiry Date 17-Jun-2016), Lot Number: 1440 (With Expiry Date 15-Aug-2016, Lot Numbers: 1450, 1460, 1470 (With Expiry Date 17-Aug-2016) and Lot Number 1480 distributed only outside of U.S. (With Expiry Date 30-Sept-2016)
Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL)  4mL vial, Rx only, Manufactured in Hungary For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454. Individual Pack NDC 0703-9040-01, Shelf Pack NDC 0703-9040-03
Presence of Particulate Matter:  particulate matter identified as glass in one vial.
PerioRx (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for Discus Dental, LLC, Ontario, CA 91761, UPC 4235 020 91701
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for DENTSPLY Professional, York, PA 17404, UPC D00513003001O
Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC., Amityville, NY 11701, NDC 5083-0720-16
Pacifico National, Inc. dba AmEx Pharmacy
Avastin (Bevacizumab) 1.25 mg/0.05 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.
Non-Sterility: Product tested positive for bacterial contamination.
Avastin (Bevacizumab) 2 mg/0.08 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.
**Domestic** AR, AZ, CA, CT, CO, DE, FL, GA, IL, LA, MI, MD, MS, MA, NY, NV, NJ, OH, OR, PA, NC, RI, TN, WA & Washington D.C; **Internationally** Algeria, Australia, Austria, Belgium, Canada, China, France, French Polynesia, Germany, Iran, Italy, Japan, Netherlands, New Zealand, Norway, Republic of Korea, Spain, Sweden, Switzerland, Thailand & United Kingdom
RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment planning and analysis of radiation therapy.
1,264 Total units (552 units domestically & 711 units internationally)
A software issue with editing tools that use the left mouse button held down, for drawing in and interacting with the patient views and beams eye views. The views can become unsynchronized with the stored data if simultaneously right clicking, pressing Ctrl-S or Ctrl-Z while the left mouse button is held down. This bug does not affect dose computations, which are based on the stored system state.
(2) lots (Lot # 700785 & 700804) of 19200 lbs each (total 38400 lbs) were made and distributed to Brand Nu Laboratories (distributor) at the following address: 377  Research Parkway, Meriden, CT 06450.     One (1) lot (LOT#700792) of 450 kg was made and distributed to M K Impex, Canada at the following address: C/O Rexway Transport, Ltd. 2869 Slough Street, Mississauga, ON. L4T 1G4.     Additional information: In the US, all of the potentially contaminated product was used in the manufacturing of drugs. In Canada, 200 kg of 450 kg of the potentially contaminated product has been distributed in Saudi Arabia while the remaining 200 kg is in the distributors control and has been put on hold.
Zinc Oxide Powder (API) used in the manufacturing of dietary supplements  .
(Lot # 700785 & 700804) of 19200 lbs each (total 38400 lbs) , lot (LOT#700792) of 450 kg was made and distributed
ZoChem Inc. received a complaint from  a customer who noticed black specs of contamination in one specific lot (#700792) of product (zinc oxide) that they received, an investigation by ZoChem Inc.  was launched .       The retained sample representing this lot was analyzed and the contaminant was determined to be iron.  The issue is potentially present in two other lots (#700785 & 700804) produced
Lot # 700785; expiration date: 07/19/2017 (manufactured 07/20/15) - US  Lot #700804; expiration date: 07/28/2017 (manufactured 07/29/15) - US   Lot# 700792; expiration date: 07/22/2017 (manufactured 07/23/15) - Canada
AA USA Trading Inc. Ginger Slice   Net Wt: 8 oz., AA USA Trading Inc. 47 Reid St. South River, NJ 08882
Ginger slices contain undeclared sulfites.
8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest, IL 60045, NDC 0409-6625-02
Presence of Particulate Matter:  particulate matter identified as an insect in one vial.
No US Distribution.  Three customers in Europe - Italy, Germany and Austria.
Organic Auricularia auricular (Dried Mushroom Powder (Jelly Ear Mushroom).    60 kg 4 mil polyethylene bags inside plastic polyethylene black drum.  Certified Organic by QAI - Made in USA.    Aloha Medicinals Inc.  2300 Arrowhead Drive  Carson City, NV 89706
One retained sample of Auricularia auricular tested positive for E-Coli. Product was tested after firm received reports  of stomach issues from wholesale customer.
Lot AA091215; Expiration date: 12/08/2018
Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.
Ref Number: 30-04  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Product packaging defective compromising sterility
Ref Number: 20-06S    Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Americot White 1.5 cm x 5.5 cm  Ref  Number: 20-31SW  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 90-02    Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Ultracot 5 mm x 13 mm (Glassine)  Ref Number: 23-02G  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Ultracot 13 mm x 60 mm (Glassine)  Ref Number: 23-08G  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 31-03  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Delicot 20 mm x 60 mm  Ref Number: 63-09    Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Ultracot 20 mm x 60 mm   Ref Number: 23-09  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Delicot non-xray 5 mm x 13 mm  Ref Number: 63-02 non-xray    Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 20-05S  Product Usage:  Neurosurgical and Nonneurosurgical Sponges    Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Delicot-J 30 mm x 70 mm  Ref Number: 63-10J  (Japan Only)    Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 60-09  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 80-06    Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Delicot 6 mm x 50 mm  Ref Number: 63-06  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 20-04S  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 30-02  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 20-19S  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Delicot-J 15 mm x 20 mm  Ref Number: 63-04J (Japan Only)    Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 67-29  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 80-13    Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 30-05  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 20-30S  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Ultracot 30 mm x 90 mm (Glassine)  Ref Number: 23-15G  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Delicot non-xray 5 mm x 8 mm  Ref Number: 63-01 Non X-Ray  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Ultracot 10 mm x 13 mm (Glassine)  Ref Number: 23-03G  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 30-03  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Ultracot 13 mm x 60 mm   Ref Number: 23-08  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 90-06    Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Ultracot 5 mm x 8 mm (Glassine)  Ref Number: 23-01G  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Large  Ref Number: 50-01  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Ultracot 20 mm x 60 mm (Glassine)  Ref Number: 23-09G  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Delicot 30 mm x 70 mm  Ref Number: 63-10    Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Ultracot 30 mm x 70 mm (Glassine)  Ref Number: 23-10G  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Ultracot 70 mm x 10090 mm   Ref Number: 23-24  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 60-12  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 20-10S  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 60-07  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 20-01S  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 30-01  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 31-04  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 80-08    Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Ultracot 15 mm x 20 mm (Glassine)  Ref Number: 23-04G  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 60-04  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Delicot 10 mm x 13 mm  Ref Number: 63-03  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 20-26S  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Delicot 5 mm x 13 mm  Ref Number: 63-02    Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 90-29    Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 80-12    Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 80-09    Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 70-02  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Ultracot 9 mm x 50 mm  (Glassine)  Ref Number: 23-07G  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 67-06  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Ultracot 30 mm x 70 mm   Ref Number: 23-10    Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 20-22S  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Delicot 15mm x 20mm  Ref: 63-04  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Delicot 4 mm x 50 mm  Ref Number: 63-05  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 20-32S  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Delicot 5 mm x 8 mm  Ref Number: 63-01  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 60-08  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Delicot X 9 mm x 50 mm  Ref Number: 63x07  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Delicot 9 mm x 50 mm  Ref Number: 63-07    Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 20-14S  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Ultracot 15 mm x 20 mm   Ref Number: 23-04  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 31-07  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 30-07  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 20-07S  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Delicot X 6 mm x 50 mm  Ref Number: 63x06  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Delicot non-xray 10 mm x 13 mm  Ref Number: 63-03 non-xray    Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 67-08  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 67-09  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Delicot 4 mm x 50 mm  Ref Number: 63-05    Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 60-13  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Delicot-J 5 mm x 8 mm  Ref Number: 63-01J (Japan Only)  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 60-15  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Ultracot 5 mm x 8 mm	  Ref Number: 23-01  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 60-02  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Mass Eye & Ear Finger Cot Nasal 2's  Ref Number: 41-04    Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 80-11    Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 90-08    Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Ultracot 6 mm x 50 mm   Ref Number: 23-06  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Delicot-J 13 mm x 60 mm  Ref Number: 63-08J (Japan only)  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 80-05    Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Ultracot 15 mm x 15 mm (Glassine)  Ref Number: 23-12G  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Delicot 30mm x 70mm  Ref: 63-10  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 60-29  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
American Surgical Delicot 13 mm x 60 mm  Ref Number: 63-08  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 30-00  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 60-22  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 67-02  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
Ref Number: 60-06  Product Usage:  Neurosurgical and Nonneurosurgical Sponges
OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-04
OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-01.
Angiodynamics Inc. (Navilyst Medical Inc.)
AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula.
Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the products may possess levels of endotoxin that exceed regulatory limits. AngioDynamics confirmed that the affected RotaFlow Centrifugal Pumps were included in packaged AngioVac Circuit Packs.
Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula.
Worldwide Distribution -- U.S., to the following states: AK, CA, FL, GA, MN, MT, NJ, OH, TX and WA; and, the country of Canada.
Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566.    Intended for the qualitative identification by light microscopy of human calretinin molecule in paraffin sections.
Novocastra Liquid Mouse Monoclonal Antibody Calretinin when used in combination with specific Lots of antibody diluent will give reduced staining.
Domestic: Unknown    Foreign: Unknown    VA/DOD:
Undisputed , all lot codes, Flavors:Fruit Punch, 330 grams packed in 20oz HDPE White Plastic Container, The product was sold in white bottles with a white cap, containing forty  (40) powder servings; 12 /case
because it contains the ingredient Acacia rigidula which does not meet the definition of a dietary ingredient.
All lot codes including the following: Fruit Punch     DOM 4/24/15   200 Units    Lot #36143399
Undisputed , all lot codes, Flavors: Lemon Lime, 330 grams packed in 20oz HDPE White Plastic Container, The product was sold in white bottles with a white cap, containing forty  (40) powder servings; 12 /case
All lot codes including the following: Lemon Lime     DOM 4/24/15   200 Units    Lot #36243599; Lemon Lime   DOM 06/2014   200 Units    Lot # 190351ULL
Undisputed , all lot codes, Flavors: Sour Apple, 330 grams packed in 20oz HDPE White Plastic Container, The product was sold in white bottles with a white cap, containing forty  (40) powder servings; 12 /case
All lot codes including the following: Sour Apple      DOM 5/5/14     100 Units    Lot #190339NBUSA  Sour Apple     DOM 8/20/14    200 Units    Lot # 190385NBUSA
Undisputed , all lot codes, Flavors: Blue Raspberry, 330 grams packed in 20oz HDPE White Plastic Container, The product was sold in white bottles with a white cap, containing forty  (40) powder servings; 12 /case
All lot codes including the following: Blue Raspberry  DOM 6/17/15  200 Units    Lot #30759499; Blue Raspberry DOM 7/2014  200 Units    Lot #190370UBR;  Blue Raspberry DOM 12/2014 300 Units   Lot #150429BR;
Undisputed , all lot codes, Flavors: Mango Orange , 330 grams packed in 20oz HDPE White Plastic Container, The product was sold in white bottles with a white cap, containing forty  (40) powder servings; 12 /case
All lot codes including the following: Mango Orange DOM 6/16/15   200 Units    Lot #31159399
Undisputed , all lot codes, Flavors: Juicy Pineapple, 330 grams packed in 20oz HDPE White Plastic Container, The product was sold in white bottles with a white cap, containing forty  (40) powder servings; 12 /case
All lot codes including the following: Pineapple      DOM 5/2014    300 Units    Lot #190337NB
Undisputed , all lot codes, Flavors: Watermelon, 330 grams packed in 20oz HDPE White Plastic Container, The product was sold in white bottles with a white cap, containing forty  (40) powder servings; 12 /case
All lot codes including the following: Watermelon    DOM 6/2014   600 Units     Lot #190353NBWW (Only run they did of this)
Distributed US (nationwide) and in Australia.
SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
Complaints of intra-operative breakage of the glenosphere impactors/extractors.
Human corneas, not tested appropriately to reduce the risk of transmission of relevant communicable diseases, were distributed.
Apheresis Platelets, Leukocytes Reduced, Irradiated
Blood products, which did not meet the acceptable product specifications, were distributed.
Blood and Blood Products for Reprocessing
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Sclerosol Intrapleural Aerosol (sterile talc powder), Intrapleural administration, 4 g Canister, Rx Only,  Distributed by: Bryan Corporation, Woburn, MA 01801, USA, NDC 63256-100-30
Defective Delivery System: Defective stem valve causes leakage of the propellant in the spray canister delivering no drug or an inadequate amount of the drug to be delivered.
Whole Dried Yellow Fish in bulk cardboard box, unlabeled, Product of China --- Fish measured 6.5 - 7.5 inches in length
The product was found to be uneviscerated based on sampling and analysis by New York State Department of Agriculture & Markets.
Central Texas Regional Blood & Tissue Center
Apheresis Red Blood Cells, Leukocytes Reduced
Blood products, in which quality control and distribution of products did not meet specifications, were distributed.
Blood product, collected from a donor for whom no documentation of an arm inspection and/or screening questions, was distributed.
Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distributed by Roerig, Division of Pfizer, Inc., NY NY 10017, NDC 0049-4910-30.
Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.
Blood product, collected from a donor who had been incarcerated, was distributed.
Red Blood Cells, Leukocytes Reduced, Irradiated
Blood products, in which donor gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked, were distributed.
Blood product, collected from a donor without documentation of a hematocrit test having been performed, was distributed.
US Nationwide distribution in the states of: AE, AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX,UT, VA, VT, WA, WI
3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile    Product Usage:  The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN).
The sterile packaging may be compromised.  A protective cap is to be secured on the tip of the drill bit.  If the protective cap is not secured, the drill bit may puncture the sterile barrier.
3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S    Product Usage:  Usage:  The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN).
Accriva Diagnostics Inc., dba ITC, dba Accumetrics
U.S. distribution to the following; state:  VA.   Foreign distribution to the following; China, Italy, Germany.
Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.
Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to either have an error code or an erroneously high result.
Directly to: MN, VT, product was further distributed to Target Stores Nationwide.
archer farms Greek-Inspired Spinach & Feta Cheese ARTISAN PIZZA, NET WT 14.9 OZ (425g). UPC Code: 0-85239-30714-4. Pizza is frozen.
Consumer found a small piece of gray plastic in the pizza.
BEST BY OCT 15, 2016  Batch Code: 5288 A2
US nationwide distribution, including  Puerto Rico and Guam.
Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles.   Catalog # M35500 (D-Vapor) and M36700 (D-Vapor 3000).  Anesthesia Vaporizer
16078 units distributed within the United States
Operators noticed unwanted release of evaporating anesthetic agent at the end of the filling procedure.    Eye contact with volatile anesthetics can result in serious irritation. Immediate eye flushing and consultation of a physician is recommended.  Updated Material Safety Data Sheets (MSDS) for Desflurane recommend wearing safety glasses when handling these substances.
Misbranded Source Plasma was distributed.
Worldwide Distribution-US (nationwide) including the states of AL, CA, CO, CT, IL, IN, MD, MN, MS, MO, NE,NV,NH, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI, and the countries of ALGERIA, BELGIUM CANADA, CHINA, FRANCE, GERMANY, HUNGARY, IRELAND, ITALY, JAPAN, MEXICO, NETHERLANDS, PERU, SAUDI ARABIA, SINGAPORE, UNITED ARAB EMIRATES, and UNITED KINGDOM.
GE Healthcare, Discovery IGS 740.  Indicated for use in generating fluoroscopic and rotational images of human anatomy.
Potential non-recoverable loss of image acquisition.   The affected Discovery systems may experience multiple X-Ray abort errors before or during a real-time fluoroscopic Interventional procedure.
GE Healthcare, Discovery IGS 730.  Indicated for use in generating fluoroscopic and rotational images of human anatomy.
Apheresis Red Blood Cells, not meeting product specification, were distributed.
Blood product, collected from an ineligible donor, was distributed.
Distributed in the state of NY and the country of Canada.
Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877.  Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.
Catalog Number: 401450  Lot Number: 2561683E  Expiration Date: 5/13/2017    Catalog Number: 401877  Lot Number: 2555866E  Expiration Date: 5/6/2017
Worldwide Distribution: US (nationwide) and countries of:  Japan, South Africa, Germany, Sweden, Belgium, France, Italy, Spain, India, Russian Federation, Hungary, Turkey, Poland, Portugal, Costa Rica, Finland, Great Britain, Croatia, India, Chile, Thailand, Mauritius, Iraq, Denmark, Norway, Ireland, Netherlands, Bulgaria, Czech Republic, Luxembourg, UAE, Austria, Poland, Pakistan, Sri Lanka, Kazakhstan, Slovakia, Saudi Arabia, Unite  Arab Emirates, Egypt., Jordan, Kuwait, Lebanon, Bulgaria, Romania, Latvia, Lithuania, Bosnia and Herzegovina, Greece, Malta, Cyprus, Romania, Tunisia, Kenya, Algeria, Israel, Jordan, Hong Kong, Republic of Korea,  Malaysia, New Zealand, Venezuela, Brazil, Philippines, Australia, Taiwan, Peru, Singapore, Panama, Mexico, Argentina, Costa Rica, Dominican Republic, China, and Paraguay,
Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits.    Cardiology: The Volcano Universal (Core /Core Mobile), S5iz Platform Imaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.
Volcano has become aware of an incompatibility issue between Impacted Systems and hospital network scans. In specific circumstances, an impacted System will encounter unexpected data from the hospital network and be forced to reboot
Plateletpheresis products, not meeting product specifications, were distributed.
Corn Seasoning Salt Blue Cheese and Herb is recalled because the label declared blue cheese but milk is not declared.
TX, NY, PA, GA, WA, ME, UT, CA, IL, MN, OR, MT, TX, NV, FL, CO, OR, NJ, SC,AZ, VA, CT, NC, WA, WI.
Mighty Leaf Tea Company Organic Ginger Peach Iced Tea;  100/1 oz. per case  Item number 60001.  UPC: 00656252600019
Firm was notified by their supplier of Organic Ginger Peach tea that it has the potential to be contaminated with Salmonella.
Distributed in the US states of CA, GA, MN, and OH, and in the Netherlands.
PerFuse Decompression Instrument PN: 800-0541, Lot:100650.  Designed to access the femoral head for decompression.
The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes.
PerFuse Decompression Instrument PN: 800-0541, Lot:100650
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
US nationwide distribution in CA, FL, IN, MI, MO, NC, NY, and TX.
Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve.  Spinal fixation device instrument.
Potential for a product defect where the cannula may be obstructed.  This obstruction could prevent a driver from going through, which increases the potential for the driver to slip, resulting in possible patient injury.
Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve; Lot Number: 170684; Part Number: 26-COUNTER-T-XLINK
Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.
Various trauma and sports medicine instruments and implants.  Plate, fixation, bone.
Insufficient seal strength on sterile barrier packaging.  The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile.  If the product becomes non-sterile and is used or implanted, it may lead to an infection.
Various trauma and sports medicine instruments and implants.  Appliance, fixation, nail/blade/plate combination, multiple component.
Various trauma and sports medicine instruments and implants.  Orthopedic manual surgical instrument.
Various trauma and sports medicine instruments and implants.  guide, surgical, instrument
Various trauma and sports medicine instruments and implants.  Pin, fixation, smooth.
Various trauma and sports medicine instruments and implants.  Bit, drill.
Various trauma and sports medicine instruments and implants.  cannula, surgical, general & plastic surgery and accessories
Various trauma and sports medicine instruments and implants.  Fastener, fixation, nondegradable, soft tissue.
Various trauma and sports medicine instruments and implants.  Arthroscope.
Various trauma and sports medicine instruments and implants.  Screw, fixation, bone.
Various trauma and sports medicine instruments and implants.  Reamer.
Various trauma and sports medicine instruments and implants.  Spinal interlaminal fixation orthosis.
Various trauma and sports medicine instruments and implants.  Rod, fixation, intramedullary and accessories.
Various trauma and sports medicine instruments and implants.  Passer.
Blood product, for which donor suitability was not adequately determined, was distributed.
Nationwide CA, CO, ID, MD, MN, OR, TN, TX, and WA.  No foreign or military/govt/VA consignees.
Bobo's Oat Bars, Gluten Free, Lemon Poppyseed, Net Weight 3 oz (85g), packaged in clear plastic, 12 bars per sleeve, also sold as individual units. Manufactured by Simply Delicious, Inc.
Simply Delicious is recalling Lemon Poppyseed bars because they were mispackaged with Coconut bars.
IL, LA, Austria, Australia, Botswana, Germany, Denmark, France, India, Japan
iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to branch into a specific catch-up workflow, which was implemented to use the initial scan data.
Apheresis products, for which quality control testing for residual white blood cell count was not performed, were distributed.
W221616301402 (double collection); W221616301391(double collection)
American Red Cross Blood Svs. Indiana-Ohio Region
Worldwide distribution: US Distribution to states of: IN, NV, MA, IL, AR, TX, OH, CA, GA, FL, MS, NJ, AL, PA, TN, KY, VA, SC, and country of: Canada.
WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units per case, Catalog Number 471734.    Usage: Infusion of solution/medication into implanted intravascular ports.
Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard.
Catalog Number 471734, Lot Numbers: 0061482060 and 0061486821, expiration dates :1/31/2021 and 02/28/2021, respectively.
Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), packaged in 10 x 300 mL Single Use Container bags per Box Pack (NDC 0703-9060-33), Rx only, Manufactured In Hungary By: Teva Pharmaceutical Works Ltd., Hungary, H-2100 Godollo, Tancsics M. ut 82 Hungary; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454
Lack of Assurance of Sterility:  Due to potential for leaking bags.
Blood Centers of the Pacific - Irwin Center
Blood product, collected from a donor who lived with an individual who had Hepatitis B, was distributed.
HCSC-Blood Center dba as Miller-Keystone Blood Center
Mislabeled blood products were distributed.
Blood products, collected from a donor who received a piercing within one year of donation, were distributed.
Human Corneas, recovered from a donor who was not properly evaluated for hemo-dilution, were distributed.
American National Red Cross Great Lakes Region