Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
CITRULLINE (L) in 25 g, 100 g, 500 g and 1 kg plastic bottles, White crystals or crystalline powder, odorless, For Use and distribution in prescription compounding, manufacturing, processing, or repackaging only in accordance with FDA regulations and applicable law, Packaged by Medisca Inc. Plattsburgh, NY 12901, USA, NDC #s: 38779-1186-4 (25 g), 38779-1186-5 (100 g), 38779-1186-8 (500 g), 38779-1186-9 (1 kg).
25 g: 15 bottles, 100 g: 153 bottles; 500 g: 18 bottles, 1 kg: 24 bottles
Labeling: Label Mix-Up: FDA tested samples of API from Medisca, labeled as to contain L-Citrulline, and results revealed no L-Citrulline was present. Levels of N-acetyl-leucine were found instead.
Mung bean sprouts packaged in 10 lb., 15 lb., and 30 lb. plastic bags.
Listeria monocytogenes was found in the mung bean sprouts and the area where the sprouts are produced.
There are no product or production codes associated with these products.
GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5).    GVL: The GlideScope Video Laryngoscope is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of a video laryngoscope and a portable video monitor.    AVL: The GlideScope AVL Video Monitor system has the same intended use as the GVL System.  The difference between systems is that the AVL has a digital platform and the GVL an analog platform.
total 9088 units ( 5786 units in the US and 3302 units International)
Verathon has revised the Operations and Maintenance Manual (OMM) to specifically state compatibility limitations of the reusable video laryngoscope Blade validated through simulated  use cycles, such that exceeding this number of cycles in the specific chemical agent may affect the potential life of the product.
Philips Electronics North  America Corporation
Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of : Canada, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Republic of Korea, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, Netherlands Antilles, New Zealand, Norway, Oman, Pakistan, occupied Palestinian territory, Panama, PERU, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom and Viet Nam.
Actuator for angiographic x-ray monitor ceiling suspension system.  Actuator short Assy: THC8AWDS-121 and Actuator long Assy: THC8AWDS-122 used with the following products: 722001  Allura Xper FD 10 C; 722003 Allura Xper FD10; 722005 Allura Xper FD10/10; 722006 Allura Xper FD20; 722008 Allura Xper FD20 Biplane; 722010 Allura Xper FD10; 722011 Allura Xper FD10/10; 722012 Allura Xper FD20; 722013 Allura XPER FD20 BIPLANE; 722015 Allura Xper FD20 OR Table; 722020 Allura Xper FD20 Biplane OR Table; 722022 Allura Xper FD10 OR Table; 722023 Allura Xper FD20 OR Table; 722025 Allura Xper FD20 Biplane OR Table; 722026 Allura Xper FD10; 722027 Allura Xper FD10/10; 722028 Allura Xper FD20; 722029 Allura Xper FD20/10; 722035 Allura Xper FD20 OR Table; 722038 Allura Xper FD20/20; 722039 Allura Xper FD20/20 OR Table; 722058 Allura Xper FD20/15; 722123 Field extensions Xper cardio R7.6; 722124 Field extensions Xper vascular R7.6; 722133 Field ext. Xper cardio systems R7.6; 722134 Field ext. Xper vascular systems R7.6; 72249 INTEGRIS BV5000; 722043 INTEGRIS Allura 15-12 (mono); 722121 Field extensions INTEGRIS cardio systems
The actuator assembly became detached and the monitor carriage with a flexvision monitor dropped to its lowest position.
Actuator short Assy: THC8AWDS-121 and Actuator long Assy: THC8AWDS-122
Akttive High Performance Fat Burner Gold dietary supplement capsules, 30-count bottle, Distributed by Life and More, L.L.C., Doral, Florida
Marketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling.
Alabama, Arkansas, Illinois, Minnesota, Ohio, and Texas
RED DIAMOND, European Roast, COFFEE CONCENTRATE, Mix Ratio 69 + 1, Net contents 1/2 Gallon, Manufactured for RED DIAMOND, Birmingham, AL;  Item # 111590
Elevated pH levels in an acidified product
RED DIAMOND, COLOMBIAN, NATURALLY DECAFFEINATED, Coffee Concentrate, Mix Ratio 69 + 1, Net contents 1/2 Gallon, Manufactured for RED DIAMOND, Birmingham, AL;  Item # 111591
RED DIAMOND, COLOMBIAN, NATURALLY CAFFEINATED, Coffee Concentrate, Mix Ratio 69 + 1, Net contents 1/2 Gallon, Manufactured for RED DIAMOND, Birmingham, AL;  Item # 111589
ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets, 325 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-642-30.
Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.
ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets, 500 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-641-30.
Nine specific hospital pharmacies in VA, IA, WI, CO, CA, PA, and OK.
fentaNYL Citrate, Preservative Free, 10 mcg per 1 mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, code 2R3174, PharMEDium
fentaNYL Citrate, Preservative Free, 5 mcg per mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, code 2R3479, PharMEDium.
Rhino 7 3000, 6 count bottles, Distributed by Rhino 7, Made in USA.
Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.
Rhino 7 Platinum 3000, Single Blister Packs, distributed By Rhino 7, Made in USA
Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA
Rhino 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA
NATUREAL BURN FAT NATURE, 30-count capsules, packaged in clear plastic bottle, Manufactured for: Inaffit, LLC. P.O. Box 34056, Bethesda, MD 20827.
Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.
Bake Rite Rolls Divison of Northeast Foods
Bakery Code: 09, Julian Code: 304, 305, Fresh Through Code: 11-11, 11-12
Paricalcitol Capsules, 4 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-665-30
Failed Tablet/Capsule Specifications:  Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Paricalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-663-30
Paricalcitol Capsules, 2 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-664-30
NY, NJ, PA VA, MD & MA through Wegmans retail stores
Wegmans ITALIAN CLASSICS BUTTERNUT SQUASH RAVIOLI, NET WT 9 OZ, UPC #77890 36434, KEEP REFRIGERATED, PRODUCT OF ITALY
Wegmans Food Markets, Inc. initiated a recall due to the presence of undeclared tree nuts (Cashews and Almonds)
U.S. distribution to the following; CA, FL.  No foreign distribution.
B&D Seafoods   Basa Choice  Swai Fillets  IQF 15 lbs x 1/case (size 5-7, 7-9, 9-11), 11 lbs 2/case (size 6-8)  Farm Raised  Distributed by B&D Seafoods, Inc.  Product of Vietnam    IQF well trimmed, boneless, skinless, belly off, fat off, red meat off    Products are packaged in cardboard boxes.
B&D Seafoods, Inc. is recalling frozen swai fillets due to the presence of nitrofurans.
Lot Numbers: 429-13385, 429-13388  Production Date: June 26, 2015
Pacific Surf Swai Fillets  IQF 2 lbs x 5/ctn, 5 lbs x 6/ctn (size 7-9)  Farm Raised  Product of Vietnam  Packed for:  PAFCO Global Seafood Services    IQF well trimmed, boneless, skinless, belly off, fat off, red meat off    Products are packaged in cardboard boxes.
Happy Fish  Swai Fillet  Farm Raised  Product of Vietnam   Net Weight: 22 lbs    IQF well trimmed, boneless, skinless, belly off, fat off, red meat off    Products are packaged in cardboard boxes.
Vitamin Supplement (Vial) D3, (cholecalciferol (vit D3)/lipoic acid/ubiquinol/ methylcobalamin/pyridoxine/methionine/inositol/choline bitartrate USP) capsules, 60, 120 or 180 count vials, Glades Drugs, 109 S. Lake Ave., Pahokee, FL 33476.
Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol).
AICACABF@3, AICECABF@2, AJBFCABF@4, ABCCABF@4, AICACABF@5, AICECABF@3, AJBHCABF@2, ABCCABF@5, AICBCABF@1, AICECABF@4, AJCBCABF@1, ABGCABF@4, AICBCABF@2, AICECABF@5, JCBCABF@2,  BACDCABF@5, AICBCABF@3, AICICABF@3, BAAGCABF@2, BADACABF@3,  AICBCABF@4, AJADCABF@1, BAAICABF@1, BACCABF@3, AICECABF@1,  AJBECABF@6, BABCCABF@2 and BBAECABF@5, Exp 02/20/2016
Worldwide Distribution - US Nationwide and the countries of   Canada, Albania, ALGERIA, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Georgia, Germany, Greece, Greece, Guatemala, Honduras, Hungary, Iceland, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Mauritius, Mexico, Monaco, Montenegro, Morocco, Namibia, Netherlands, Nicaragua, Nigeria, Norway, Panama, Paraguay, Peru, Poland, Portugal, Romania, Russia, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, UAE, Ukraine, United Kingdom, Uruguay, Venezuela, and Zimbabwe.
Covidien Endo GIA Ultra Universal  12 mm Short Stapler Handle  Ref: EGIAUSHORT    Product Usage:  The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers when used with the Endo GIA curved tip single use reloads can be used to blunt dissect or separate target tissue from other tissue.
Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use
RANGES OF LOT NUMBERS  (all lot numbers within each range are affected)  Lot # starting with P3C through P5B0289X   P5C0196X through P5C0197X   P5C0304X through P5C0307X   P5C0796X through P5C0798X   P5D0049X through P5D0051X   P5D0146X through P5D0148X   P5E0261X through P5E0262X   P5F0158X through P5F0161X    INDIVIDUAL LOT NUMBERS  (in addition to ranges)  N3F0260RX                  N3F0266RX                  N3F0267RX  P5C0201X  P5D0538X   P5E0680X   P5E0682X   P5E0686X  P5E0760X  P5E0762X                    P5E0765X
Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle  Ref: EGIAUXL    Product Usage:  The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers when used with the Endo GIA curved tip single use reloads can be used to blunt dissect or separate target tissue from other tissue.
Lot numbers within each range are affected:  Lot # starting with P3C through P5B0454X, P5B0468X, P5C0152X through P5E0450X.    Individual Lot Number: P5B0468X, P5E0523X, P5E0273X
Covidien Endo GIA Ultra Universal Standard Stapler Handle  Ref: EGIAUSTND    Product Usage:  The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers when used with the Endo GIA curved tip single use reloads can be used to blunt dissect or separate target tissue from other tissue.
RANGES OF LOT NUMBERS  (all lot numbers within each range are affected)  Lot # starting with P3C through P5B0521X P5D0410X through P5D0411X P5D0823X through P5D0829X   P5E0080X through P5E0082X   P5E0317X through P5E0320X   P5E0322X through P5E0324X   P5F0001X through P5F0002X    INDIVIDUAL LOT NUMBERS  (in addition to ranges)  P5C0239X, P5C0241X, P5C0508X, P5C0510X,  P5C0512X,  P5C0597X P5C0599X, P5C0601X, P5C0603X, P5C0684X, P5C0803X, P5C0805X, P5C0807X. P5E0527X, P5E0529X      P5D0067X, P5D0069X , P5D0073X, P5D0170X,  P5D0413X,  P5D0415X ,P5D0417X, P5D0419X, P5D0447X, P5D0623X, P5D0624X ,P5D0626X, P5D0628X	    P5D0630X, P5E0525X,  P5F0004X, P5F0006X,  P5F0008X, P5F0010X, P5F0014X, P5F0017X, P5F0019X, P5F0021X, P5F0213X, P5F0217X
Worldwide Distribution - USA (nationwide) Distribution and to the countries of :  Argentina, Australia, Austria, Belgium, Chile, Denmark, France, Germany, Greece, Hong Kong, Italy, Japan , Netherlands, Romania  Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey and UK.
The Firm  informed the importer/distributor, Leica Microsystems, a manufacturing error occurred during the filling of some containers of the Bond Polymer Refine Red Detection DS9390 kits, which may result in inadequate staining.
Nationwide in the U.S.A. via the website.
Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 of 3, fit firm & fabulous, UPC 5 42423 25422 1.
Marketed Without An Approved NDA/ANDA: product marketed as a dietary supplement was found to be tainted with undeclared sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug.
Argindione, sold as bulk of 50,000 capsules.
Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because lack of adequate GMPs.
Prostax Forte, sold in bulk of 50,000 capsules.
Neuro-Cetin, sold in bulk 50,000 capsules.
Chardon de Marie, 60 capsules per bottle. Manufactured by Sunset Natural Products
Venocell, sold in bulk of 50,000 capsules.
Moinsage, 60 capsules per bottle. Manufactured by Sunset Natural Products
Abee Med, 60 capsules per bottle. Manufactured by Sunset Natural Products
Prostaliv, 60 capsules per bottle. Manufactured by Sunset Natural Products
Hepasil, sold in bulk of 500,000 capsules.
Prostamax DUO, 60 capsules per bottle. Manufactured by Sunset Natural Products
Dried Tai Sweet Mango Slice, Net Wt: 8 oz., UPC 6 944155 210102
AA USA Trading Inc. is recalling Dried Tai Sweet Mango Slice (NYSDAM FL: 378858) because the product contains undeclared FD&C Yellow #6 and Dried Kiwi Slice (NYSDAM FL: 378859) because this product contains undeclared FD&C Blue #1, Yellow #5 and undeclared sulfites.
Dried Kiwi Slice, Net Wt: 8 oz., UPC 6 944155 210041
AA USA Trading Inc. is recalling Dried Tai Sweet Mango Slice (FL 378858) because the product contains undeclared FD&C Yellow #6 and Dried Kiwi Slice (FL 378859 because this product contains undeclared FD&C Blue #1, Yellow #5 and undeclared sulfites.
Worldwide Distribution -- US, including the states of AL, AR, CA, FL, GA, ID, IL, KS, MA, MI, MO, NC, TN, TX, and AK; and, country of Japan.
High Flow Irrigation Extender; Part Number 72201021.    Arthroscopic accessories are indicated for use in access of the joint capsule.
During arthroscopic surgery, when the scope is moved inside the cannula, the body of the irrigation extender separates, potentially obstructing visualization and causing leakage of the irrigation fluid. The device is removed and a back-up device is used to complete the surgery.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed
US Nationwide Distribution - in the states of:  AL, AZ, CA, CO, FL, GA, IL, IN, IA, KS, KY, LA, MD, MI, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, PA, SC, TN, TX, VA, WA, WV, and Puerto Rico
REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx Only, Latex Free, 50 units.    Product Usage:  Product is intended for Resectoscope irrigation, catheter irrigation and Foley catheter inflation.
Report by a customer of an open package seal.
Baked, W/WO Icing Soft Pretzel in rigid plastic labeled as:  New Year's Pretzel  Sell By: 01/04/2016    PLU: 39739  UPC: 23979 80499
Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g Total, 50 mL Single-Dose Container bag, Hospira, Inc., Lake Forest, IL  60045, NDC 0409-6729-24.
Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium.
US: AL CA CT FL IL MA MI MS MT NJ NY OH OK ON PA SC TX VA VT WA WI  OUS: Canada and Bermuda
Blood and Blood Products for Reprocessing
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
All product is sold to Ace Distributors, LLC in Orlando, FL, a retail store, who sells directly to owners of gas stations, convenience stores, and smoke shops where it can be further distributed nationwide.
APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL  USA; UPC 7 05105 96361 7.
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug.
US Nationwide Distribution including Puerto Rico.
EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's Manual. in vitro diagnostic      Product Usage:  EVOLIS Microplate System is a 4 plate fully integrated microplate processing system designed for use with multiple EIA assays.
level low alarmed, which prompted the customer to open the system drawer. When the system drawer was opened the customer noted the plate transport was still running and as a consequence the plate was pushed off the plate transporter.
U.S. distribution to the following; CA, TX, GA, NY, and FL  No foreign distribution.
Kleancolor   Bow-Tux Volumizing Mascara  10.94 ml    UPC Codes: 8-10236-00878-3
Genosco dba Kleancolor is recalling Kleancolor Lash Bow-Tux Volumizing Mascara because of potential Bacillus cereus, Staphylococcus epidermidis, and Staphylococcus warneri contamination.
LOT NUMBER: GMX414A  Item number: MS1878
US distribution in the state of FL and PA.
Exactech Acapella One Interbody Fusion Device Parallel.  Orthopedic Spinal Surgery Device.      Product Usage: The Acapella One Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Is to be used with autogenous bone graft and supplemental internal fixation and is implanted via an open anterior approach.
Incorrect external and internal packaging labels. Exactech has identified nineteen (19) Acapella One Interbody Fusion Device Lordotic (05-090-01-1610) were packaged as Acapella One Interbody Fusion Device Parallel (05-090-02-1610)
Glazers Donuts,  3977904033 040337, 6 PK in cardboard bakery box (fresh).
approx. 288755.44 product counts for all products
Kwik Trip, Inc. is recalling various bakery goods which might be contaminated with pieces of  plastic due to using plastic contaminated ice nuggets as an ingredient.
All lots manufactured prior to but not including 01/13/2016.
Persian,  9999954011 540112,  24 per bulk tote, frozen.
Custard Bismark 9999954007,  540070, 24 per bulk tote.
Jelly Bismark 9999954008,  540088,  24 per bulk tote.
Cinnamon Cinnsations,  4 count Net WT 19 oz (540g),  3977953052,  530530.
Triple Choc Bismark 9999954048,  540484,  24 per bulk tote.
KBS Cinn Raisin  Bagel,  9999953937,  539158,  24 per bulk tote.
Plain Long Johns 9999954013,  540138 each, product shipped frozen (28 per bulk tote).
Filled Long Johns 9999954006,  540062, 28 per bulk tote.
KBS Bagel Cinnamon Crunch Bagel,  9999953939,  539160, 24 per bulk tote.
KBS Plain Bagel,  9999953936,  539157,  24 per bulk tote.
US Distribution to the states of : CA, FL, MO & WI., and Internationally to Republic of Korea.
MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.
The system loaded a completion fraction in the incorrect order after a treatment interruption.
papaverine phentolamine prostaglandin; 35/1.2 mg/20 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
papaverine phentolamine prostaglandin; 35/2 mg/40 mcg/mL,  10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
Estradiol cypionate/Test cyprionate; 2 mg/50 mg/ml, unit size 5 mL, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
hydroxyprogesterone in sesame 250 mg/mL, 2 mL, 5 mL, 6 mL, 8 mL unit sizes, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
methylcobalamine 4 mg/mL, 5 mL and 30 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
papaverine phentolamine prostaglandin; 30/1 mg/10 mcg/mL;  5 mL, 7 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
papaverine phentolamine prostaglandin; 25/1 mg/30 mcg/mL;  10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
papaverine phentolamine prostaglandin; 30/2 mg/25 mcg/mL;   5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
hydroxyprogesterone w/ pres; 1 mg/mL, 20 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
testosterone cypionate, 200 mg/mL, 6 mL and 10 mL unit sizes, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
Folic Acid, 10 mg/mL, 6 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
papaverine phentolamine prostaglandin; 30/2 mg/20 mcg/mL;   5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
papaverine phentolamine prostaglandin; 30/1.5 mg/40 mcg/mL;  5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
papaverine phentolamine prostaglandin; 25/0.83 mg/10 mcg/mL;  10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
papaverine phentolamine prostaglandin; 25/0.83 mg/20 mcg/mL;  5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
papaverine phent, 25 mg/0.833 mg/mL, 20 mL unit size  Refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
testosterone cypionate, 100 mg/mL, 10 mL unit size, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
papaverine phentolamine prostaglandin; 12/1 mg/30 mcg/mL;  10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
papaverine phentolamine prostaglandin; 22.5/0.83 mg/15 mcg/mL; 5 mL  unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
papaverine phentolamine prostaglandin; 30/1 mg/20 mcg/mL;  5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
papaverine phentolamine prostaglandin; 9/1 mg/10 mcg/mL,  10 mL, unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
progesterone/testosterone (ss oil) 0.25/20 mg/mL, 10 mL unit size, room temperature, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
Bupivacaine, 0.25%, 450 mL, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
Insulin, 70/30, 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
papaverine prostaglandin 30 mg/30 mcg/mL, 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
papaverine phentolamine prostaglandin; 12/0.83 mg/10 mcg/ml; 5 mL and 10 mL unit size; refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
papaverine phentolamine prostaglandin; 25/1.5 mg/15 mcg/mL;  10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
Folic Acid, 5 mg/mL, 30 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
papaverine phentolamine prostaglandin; 18/0.6 mg/6 mcg/mL;  10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
papaverine phentolamine prostaglandin; 35/1.5 mg/50 mcg/mL,  5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
papaverine prostaglandin 30 mg/20 mcg/mL, 10 mL unit size;  refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
Hydroxycobalamine 30 mg/mL, 90 mL unit size, refrigerate,   This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
papaverine phentolamine 30 mg/1mg/mL, 5 mL and 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
papaverine phentolamine prostaglandin; 30 mg/0.25 mg/10 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
calcium elemental, 3 mg/10 mL, 200 mL unit: This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
papaverine phentolamine prostaglandin; 12/1 mg/9 mcg/mL;  5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
papaverine phentolamine prostaglandin; 17.16/0.57 mg/19.45 mcg/mL; 5 mLunit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
papaverine phentolamine prostaglandin; 12/1 mg/10 mcg/mL  5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
papaverine phentolamine prostaglandin; 22.5/0.83 mg/8.3 mcg/mL; 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
papaverine phentolamine prostaglandin; 35/2.5 mg/1 mcg/mL,  10 mL, unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
methylcobalamine 10 mg/mL, 10 mL and 12 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
methylcobalamine 1 mg/mL, 1 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
papaverine phentolamine, 35 mg/2.5 mg/mL; 5 mL  unit size;   refrigerate,This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
Worldwide Distribution - US Nationwide and the countries of Albania, Guadeloupe, Norway,Algeria, Guam, Pakistan, Argentina, Guatemala, Panama,Australia, Hong Kong, Paraguay, Austria, Hungary, Peru,Azerbaijan, Iceland, Philippines, Bangladesh, India, Poland,Belgium,  Indonesia ,Portugal, Belorussia, Iran, Puerto Rico,Brazil, Iraq, Qatar, Brunei Darussalam, Ireland, Reunion,Bulgaria, Israel, Romania, Burma, Italy, Russia,'Canada, Jamaica, Saudi Arabia, Chile, Japan, Singapore, China,  Kazakhstan, Slovakia, Colombia, Kuwait, South Africa, Costa Rica, Latvia, South Korea,Czech Republic, Lebanon, Spain, Denmark, Libya, Sweden, Dominican Republic, Lithuania, Switzerland, Ecuador, Luxembourg, Taiwan, Egypt, Macau, Thailand, El Salvador, Macedonia, Trinidad and Tobago, Estonia, Madagascar, Tunisia, Finland, Malaysia, Turkey, France, Malta, Ukraine, French Polynesia, Mexico, United Arab Emirates, Georgia, Monaco, United Kingdom, Germany, Morocco, Venezuela, Ghana, Netherlands, Vietnam,Greece, New Zealand, and  Zimbabwe.
Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6;  Model number: H48;    Product Usage:  The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments.
When using PBC 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments for Eclipse versions 11.0, 13.0, 13.5 or 13.6, the displayed dose does not correspond to the calculated Monitor Units (MU).  Potential for unintended radiation exposure.
Worldwide:Distribution - US Nationwide and the countries of  Saudi Arabia, Bahrain, Australia, United Arab Emirates, Qatar, Mexico, Guam and the Bahamas.
Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32.      Product Usage:   An accessory for the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations. The Jadak Barcode Scanner is used to scan medication labels during refill of the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations and dispensing medication for patients.
Customers reported issues when scanning medications with the scanners.  When a user scans a medication using the affected barcode scanner, information on a different medication could be communicated to the Pyxis product.
distributed in AK, ID, CA, MT, OR, and WA.
Umpqua Peppermint Candy Ice Cream, Item no. 11150, 3 Gallon container, UPC 0 71203 08645 0
Umpqua Peppermint Candy Ice Cream was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test.
Pint Umpqua Dairy Nonfat Cottage Cheese, item no. 04847, Net wt. 16 oz., UPC 0 71203 00373 0
Umpqua Dairy Nonfat Cottage Cheese was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test.
Pint Umpqua Dairy Cultured Sour Cream, Item no. 03654, net w. 16 oz.; UPC 0 71203 00403 4.    Half Pint Umpqua Dairy Cultured Sour Cream, Item no. 03751, net w. 18 oz.; UPC 0 71203 00401 0.
Sour cream was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test.
Umpqua Lowfat Vanilla Soft Serve Ice Cream Mix 4% (Red), item no. 04952, Half gallon container.  UPC 0 71203 00494 2.
Umpqua Lowfat Vanilla Soft Serve Ice Cream Mix 4% (Red) was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test.
Umpqua Peppermint Candy Ice Cream, Item no. 12904, 1.75 quart container, UPC 0 71203 08793 8
Sunshine Empress Vanilla Ice Cream, item no. 12175, 3 gallon container. No UPC code.
Sunshine Empress Vanilla Ice Cream was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test.
Umpqua French Vanilla Ice Cream, Item no. 12750, 1.75 Quart container, UPC 0 71203 08751 8
Umpqua French Vanilla Ice Cream was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test.
Pint Umpqua Dairy 1.5% Lowfat Cottage Cheese, item no. 04839, net wt. 16 oz. UPC 0 71203 00360 0.    3 lbs. Umpqua Dairy 1.5% Lowfat Cottage Cheese, item no. 04146, net wt. 3 lbs.. UPC 0 71203 00376 1.
Umpqua Dairy 1.5% Lowfat Cottage Cheesewas made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test.
Umpqua Birthday Cake Ice Cream, Item no. 12815, 1.75 quart container, UPC 0 71203 08793 8
Umpqua Birthday Cake Ice Cream was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test.
Dairy Queen Vanilla Soft Serve Mix, item no. 04960, 5 gallon container. UPC 0 71203 00489 8
Dairy Queen Vanilla Soft Serve Mix was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test.
Umpqua Vanilla Ice Cream, item no. 09997, 3 gallon container. UPC 0 71203 08620 7
Umpqua Vanilla Ice Cream was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test.
Dairy Queen Chocolate Soft Serve Mix, item no. 04979, 5 gallon container.  UPC 0071203004874
Dairy Queen Chocolate Soft Serve Mix was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test.
Pint Umpqua Dairy 4% Cottage Cheese, item no. 04308, Net wt. 16 oz. UPC 0 71203 00248 1    24 oz. Umpqua Dairy 4% Cottage Cheese, item no. 04286, UPC 0 71203 00255 9.    3 lbs.  Umpqua Dairy 4% Cottage Cheese, item no. 03980, UPC 0 71203 00280 1.
2656/16 oz. units; 2001/24 oz. units; and 957/3 lbs. units.
Umpqua Dairy 4% Cottage Cheese was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test.
Umpqua Mountain Blackberry Revel Ice Cream, Item no. 12823, 1.75 quart container, UPC 0 71203 08758 7
Umpqua Mountain Blackberry Revel Ice Cream was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test.
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Worldwide distribution.  US nationwide, Australia, Austria, France, Germany, Greece, Japan, Romania, South Africa, South Korea, Spain, and United Kingdom.
MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers)  Electromyography. (EMG)
The MEE-1000A Neuromaster had defective printed circuit boards (PCBs). Gas arrestors on these boards which were intended to provide protection from electrostatic discharge failed to prohibit unintentional current flow.
Worldwide Distribution - US including CA, NY, GA, MS, PA, MA, TX, KY, AZ. and Internationally to Greece, France, Germany, Singapore and Serbia.
Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recommended 1:250.
Product Code: RB-368-R7; RB368-R1,  Lot Number  368R1407A  368R1407C  368R1407D  368R1407E, all with expiry dates of July 2016.  Product code: RB368-R1,  Lot Number 368R1407B.
Distributed in the states of TN, WI, OH, and KS, and in the countries of Belgium, Germany, and United Kingdom.
LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL;  Tibial knee prosthesis, augment.
The package for catalog item, a LEGION Hemi Stepped Tibial Wedge, 5 MM Size 5-6 LT-LAT/ RT-MDL, should include both a screw-on hemi stepped tibial wedge and two tibial wedge screws to affix the wedge to the tibial baseplate. A complaint was received indicating that the screws packaged with the wedge were  too long.
Menthocin Patch with Lidocaine-Strong (Menthol 5%, Capsaicin 0.0375%, Methyl Salicylate 20%, Lidocaine 0.5%), packaged in a box 15 patches, RX Only, Manufactured for Bonita Pharmaceuticals LLC 6380 Commerce Drive Westland, MI  48185-9120, USA NDC 53598-0012-15
US Distribution to CA., and Internationally to Canada.
Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product is packed in a sealed pouch, ten (10) pouches per case.  Cardiopulmonary bypass catheter.
Sorin Group initiated field correction for the Dual Stage Venous Return Catheter because the incorrect Instructions For Use (IFU) was packaged in the case.
American Red Cross Blood Services Heart of America Region
Little Temptations Sour Strawberries Net Wt. 7.5 oz (213g)   Packed by: Crystal Temptations, North Arlington, NJ 07031  UPC 611190469401
Sour strawberries contain undeclared FD&C Blue #1 and Yellow #5.
TEARS Naturale FREE (dextran 70 and hypromellose 2910) lubricant eye drops, 1% and 0.3%, Preservative Free, 0.9 mL (0.03 FL OZ) Single-Use Vials, packaged in 60-count Single-Use Vials per carton, Manufactured for: Alcon Laboratories, Inc., Fort Work, TX  76134, Barcode 90016741106, UPC 3 00650 41636 8.
Lack of Assurance of Sterility: Some single-use vials may be filled with water rather than the product solution and the firm cannot guarantee the sterility of the water-filled vials.