FDA recalls: February 2016
Every food and drug recall report the FDA published in February 2016: 270 reports, 54 of them Class I.
- Recall reports
- 270
- Class I (serious)
- 54
- Food
- 131
- Drugs
- 139
- Feb 24, 2016ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets, 500 mg, 100-count bottle, Distribut…Drug · Medline Industries IncLabeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.Class I
- Feb 24, 2016ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets, 325 mg, 100-count bottle, Distrib…Drug · Medline Industries IncLabeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.Class I
- Feb 24, 2016Akttive High Performance Fat Burner Gold dietary supplement capsules, 30-count bottle,…Drug · Life and More LLCMarketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling.Class I
- Feb 24, 2016Menthocin Patch with Lidocaine-Strong (Menthol 5%, Capsaicin 0Drug · Bonita Pharmaceuticals, LLCMarketed without an approved NDA/ANDAClass II
- Feb 24, 2016TEARS Naturale FREE (dextran 70 and hypromellose 2910) lubricant eye drops, 1% and 0Drug · Alcon Research, Ltd.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.Class II
- Feb 24, 2016APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by:…Drug · Nuway Distributors, LLCMarketed 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 u…Class I
- Feb 24, 2016Magnesium Sulfate in Water for Injection, (0Drug · Hospira Inc.Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium.Class I
- Feb 24, 2016Vitamin Supplement (Vial) D3, (cholecalciferol (vit D3)/lipoic acid/ubiquinol/ methylco…Drug · Glades Drugs Inc.Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol).Class I
- Feb 24, 2016Rhino 7 3000, 6 count bottles, Distributed by Rhino 7, Made in USADrug · MSNV, Inc dba National Video SupplyMarketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.Class I
- Feb 24, 2016Rhino 7 Platinum 3000, Single Blister Packs, distributed By Rhino 7, Made in USADrug · MSNV, Inc dba National Video SupplyMarketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.Class I
- Rhino 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA
- Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA
- CITRULLINE (L) in 25 g, 100 g, 500 g and 1 kg plastic bottles, White crystals or crysta…
- NATUREAL BURN FAT NATURE, 30-count capsules, packaged in clear plastic bottle, Manufact…
- Bupivacaine, 0
- calcium elemental, 3 mg/10 mL, 200 mL unit: This Rx is Compounded, Abbott's Compounding…
- Estradiol cypionate/Test cyprionate
- Folic Acid, 5 mg/mL, 30 mL unit size, refrigerate, This Rx is Compounded, Abbott's Comp…
- Folic Acid, 10 mg/mL, 6 mL unit size, refrigerate, This Rx is Compounded, Abbott's Comp…
- Hydroxycobalamine 30 mg/mL, 90 mL unit size, refrigerate, This Rx is Compounded, Abbo…
- hydroxyprogesterone in sesame 250 mg/mL, 2 mL, 5 mL, 6 mL, 8 mL unit sizes, This Rx is…
- hydroxyprogesterone w/ pres
- Insulin, 70/30, 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compoundi…
- methylcobalamine 10 mg/mL, 10 mL and 12 mL unit sizes, refrigerate, This Rx is Compound…
- methylcobalamine 1 mg/mL, 1 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded…
- methylcobalamine 4 mg/mL, 5 mL and 30 mL unit sizes, refrigerate, This Rx is Compounded…
- papaverine prostaglandin 30 mg/30 mcg/mL, 5 mL unit size, refrigerate, This Rx is Compo…
- papaverine prostaglandin 30 mg/20 mcg/mL, 10 mL unit size
- papaverine phentolamine 30 mg/1mg/mL, 5 mL and 10 mL unit size, refrigerate, This Rx is…
- papaverine phentolamine, 35 mg/2
- papaverine phentolamine prostaglandin
- papaverine phentolamine prostaglandin
- papaverine phentolamine prostaglandin
- papaverine phentolamine prostaglandin
- papaverine phentolamine prostaglandin
- papaverine phentolamine prostaglandin
- papaverine phentolamine prostaglandin
- papaverine phentolamine prostaglandin
- papaverine phentolamine prostaglandin
- papaverine phentolamine prostaglandin
- papaverine phentolamine prostaglandin
- papaverine phentolamine prostaglandin
- papaverine phentolamine prostaglandin
- papaverine phentolamine prostaglandin
- papaverine phentolamine prostaglandin
- papaverine phentolamine prostaglandin
- papaverine phentolamine prostaglandin
- papaverine phentolamine prostaglandin
- papaverine phentolamine prostaglandin
- papaverine phentolamine prostaglandin
- papaverine phentolamine prostaglandin
- papaverine phentolamine prostaglandin
- papaverine phentolamine prostaglandin
- progesterone/testosterone (ss oil) 0
- testosterone cypionate, 200 mg/mL, 6 mL and 10 mL unit sizes, This Rx is Compounded, Ab…
- testosterone cypionate, 100 mg/mL, 10 mL unit size, This Rx is Compounded, Abbott's Com…
- papaverine phent, 25 mg/0
- Paricalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr
- Paricalcitol Capsules, 2 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr
- Paricalcitol Capsules, 4 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr
- Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 of 3, fit f…
- fentaNYL Citrate, Preservative Free, 5 mcg per mL In 0
- fentaNYL Citrate, Preservative Free, 10 mcg per 1 mL In 0
- Dried Tai Sweet Mango Slice
- Dried Kiwi Slice
- Abee Med, 60 capsules per bottle
- Argindione, sold as bulk of 50,000 capsules
- Chardon de Marie, 60 capsules per bottle
- Moinsage, 60 capsules per bottle
- Neuro-Cetin, sold in bulk 50,000 capsules
- Prostaliv, 60 capsules per bottle
- Prostamax DUO, 60 capsules per bottle
- Prostax Forte, sold in bulk of 50,000 capsules
- Venocell, sold in bulk of 50,000 capsules
- B&D Seafoods Basa Choice Swai Fillets IQF 15 lbs x 1/case (size 5-7, 7-9, 9-11), 11…
- Pacific Surf Swai Fillets IQF 2 lbs x 5/ctn, 5 lbs x 6/ctn (size 7-9) Farm Raised Pr…
- Happy Fish Swai Fillet Farm Raised Product of Vietnam Net Weight: 22 lbs IQF we…
- Little Temptations Sour Strawberries Net Wt
- Glazers Donuts, 3977904033 040337, 6 PK in cardboard bakery box (fresh)
- Plain Long Johns 9999954013, 540138 each, product shipped frozen (28 per bulk tote)
- Filled Long Johns 9999954006, 540062, 28 per bulk tote
- Jelly Bismark 9999954008, 540088, 24 per bulk tote
- Custard Bismark 9999954007, 540070, 24 per bulk tote
- Triple Choc Bismark 9999954048, 540484, 24 per bulk tote
- Cinnamon Cinnsations, 4 count Net WT 19 oz (540g), 3977953052, 530530
- Persian, 9999954011 540112, 24 per bulk tote, frozen
- KBS Bagel Cinnamon Crunch Bagel, 9999953939, 539160, 24 per bulk tote
- KBS Cinn Raisin Bagel, 9999953937, 539158, 24 per bulk tote
- KBS Plain Bagel, 9999953936, 539157, 24 per bulk tote
- Marky's Puto Seko Special
- Dark Chocolate, Milk Chocolate, & Yogurt Covered cranberries
- 100% Whole Grain Hot Dog Rolls
- Wegmans ITALIAN CLASSICS BUTTERNUT SQUASH RAVIOLI
- Uncle Buck's Fish Batter Mix Original, packaged in 22 oz
- Pint Umpqua Dairy Cultured Sour Cream, Item no
- Umpqua French Vanilla Ice Cream, Item no
- Umpqua Birthday Cake Ice Cream, Item no
- Umpqua Mountain Blackberry Revel Ice Cream, Item no
- Umpqua Peppermint Candy Ice Cream, Item no
- Umpqua Peppermint Candy Ice Cream, Item no
- Umpqua Lowfat Vanilla Soft Serve Ice Cream Mix 4% (Red), item no
- Dairy Queen Vanilla Soft Serve Mix, item no
- Dairy Queen Chocolate Soft Serve Mix, item no
- Umpqua Vanilla Ice Cream, item no
- Sunshine Empress Vanilla Ice Cream, item no
- Pint Umpqua Dairy 4% Cottage Cheese, item no
- Pint Umpqua Dairy 1
- Pint Umpqua Dairy Nonfat Cottage Cheese, item no
- Mung bean sprouts packaged in 10 lb
- Baked, W/WO Icing Soft Pretzel in rigid plastic labeled as: New Year's Pretzel Sell B…
- Hepasil, sold in bulk of 500,000 capsules
- RED DIAMOND, COLOMBIAN, NATURALLY CAFFEINATED, Coffee Concentrate, Mix Ratio 69 + 1
- RED DIAMOND, European Roast, COFFEE CONCENTRATE, Mix Ratio 69 + 1
- RED DIAMOND, COLOMBIAN, NATURALLY DECAFFEINATED, Coffee Concentrate, Mix Ratio 69 + 1
- Pramipexole Dihydrochloride Tablets 0
- SyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle specially for…
- SyrSpend SF, Suspending Base, Grape Flavored, a convenient, sweetened, sugar-free syrup…
- SyrSpend SF, Suspending Base, a convenient, sweetened, sugar-free syrup-suspending vehi…
- Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups, packaged in 2 shelf boxes, one sh…
- Morphine Sulfate, 2 mg per mL (60 mg per 30 mL) 30 mL total volume in a 35 mL Monoject…
- Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (…
- Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Distributed…
- Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL 15 mL amber bottle, Rx Only, Man…
- Inclusion chocolate bar 66% Cacao topped with pistachios, cranberries & Sea Salt in a…
- Mendiant Orange apricot & carmelized hazelnut packaged in a clear plastic bag with brow…
- Inclusion bar-macadamia nuts, raspberries, and kaffir lime
- Inclusion bar-candied ginger, candied orange peel, and coriander
- Inclusion bar-strawberries, rose petals, and pink peppercorns
- Inclusion bar-strawberries, rose petals, and pink peppercorns
- Inclusion bar-cherries, cocoa nibs, cayenne
- Inclusion bar-strawberries, mangoes, and chiles
- Inclusion bar-expresso, cherries, and hazelnuts
- Inclusion bar-scorpion pepper, bourbon, smoked sea salt, and caramel pecans
- Inclusion bar-Cocao Nibs, caramel almonds, and sea salt
- Meltaway bar-black cherry lemonade
- Meltaway bar- Sweet basil & Cherry blossom
- Meltaway bar- Blood Orange & Vanilla bean
- Mendiant- Pistachio, Rose Petal & Candied Ginger
- Meltaways- 3 piece peppermint meltaways
- Meltaways- 3 piece Vanilla Sea Salt meltaways
- Meltaways- 3 piece Tahitian Vanilla Lemon Meltaways
- Meltaways- 3 piece Blood Orange meltaways
- Meltaways- 3 piece meltaways assorted
- Meltaway bar- French Vanilla & salted Almond
- Kraft Singles American packaged in a blue box with white lettering
- Kraft Singles White American singles packaged in a blue box with white lettering
- Kraft Singles Deli Deluxe American Slices packaged in a blue box with white lettering
- Zzang! Original Candy Bar, 2
- Zzang! Cashew Cow Candy Bar,2 oz
- Zzang! Wowza Candy Bar,3 oz
- Zzang! Holiday 4 pack Candy Bars, 10
- Chocolate Marshmallows, 8 oz
- Open Nature Whole Grain White Hot Dog Buns
- Open Nature Seeded Sandwich Rolls
- Safeway Kitchens Enriched Hamburger Buns
- Pantry Essentials Hot Dog Buns
- Pantry Essentials Hamburger Buns
- Signature Kitchens 100% Whole Wheat Hot Dog Buns
- Signature Kitchens Enriched Hamburger Buns, Sesame
- Signature Kitchens Crushed Wheat Hot Dog
- Signature Kitchens Enriched Hot Dog
- Coast to Coast Parisian Style French 6 Hoagie Rolls
- Coast to Coast San Francisco Style Sourdough 6 Hoagie Rolls
- Coast to Coast Traditional Hawaiian Sweet 12 Dinner Rolls
- Old Fashioned White Diner Rolls 8 Count Pack size 20 oz
- Old Fashioned Wheat Diner Rolls 8 Count Pack size 20 oz
- Celestial Seasonings Roastaroma Herbal Tea Lot code: Best Before 20DEC17 Pack size: 6 r…
- WATCHAREE'S thai peanut sauce (UPC 094368999977), product is in a glass jar
- WATCHAREE'S Thai Massaman curry sauce (UPC 094368999984), product is in a glass jar
- Watcharee's Thai Green Curry Sauce (UPC 094368999991), product is in a glass jar
- Whole cucumbers
- Sliced cucumbers
- Label reading in part: "CRIADA***PREMIUM GANDULES VERDES GREEN PIGEON PEAS***In water…
- Label reading in part: "ECONO***Gandules Verde***Hervidos en Agua y Sal*** Green Pigeon…
- Bearded Brothers BOLD Coconut Curry Net Wt
- Bearded Brothers BOLD The Greek Net Wt
- FATwater bottle, 16
- FATwater bottle, 16
- FATwater bottle, 16
- Sunbest Natural Lemon Juice 33
- Lyrica (pregabalin) capsules, 50 mg, 90-count bottle, Rx only, Distributed by: Parke-Da…
- Lyrica (pregabalin) capsules, 75 mg, 90-count bottle, Rx only, Distributed by: Parke-Da…
- Clonazepam Tablets, USP, 0
- Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrigo, Minneap…
- Nystatin, USP Powder for Rx compounding, 150 Million Units, Packaged by Perrigo, Minnea…
- Zatarain's New Orleans Style RED BEANS AND RICE, ORIGINAL
- Tonkutsu Ramen
- This Kid Saves Lives Chocolate Chip UPC #10858497004097 UPC# 858497004090
- Signature Cafe Traditional Stuffing
- Signature Breads Frozen Parbaked French Dinner Roll 22245
- Signature Breads Frozen Parbaked Baguette 22202, 25 UNITS - 8
- Signature Breads Frozen Parbaked French Petit Pain 22203, 144 UNITS - 1
- Signature Breads Frozen Parbaked French Sub Roll 22201, 72 UNITS - 3
- Piantedosi French Dinner rolls C-301, Signature Breads French Dinner Rolls 22200, 240 U…
- Signature Breads Frozen Parbaked French Dinner Rolls 22251
- Signature Breads Frozen Parbaked French Mini Baguette 22205
- Signature Breads Frozen Parbaked French Sub Grande 22089
- Signature Breads Frozen Parbaked Assorted Petit Pain 22032
- Signature Breads Frozen Parbaked Assorted Dinner Rolls 22213
- Tong Ren Tang Shenjing Shuairuo Wan Herbal Supplement 240 pills UPC Code: 6 90457…
- Bakery Oatmeal Raisin Cookies packaged in clear plastic clamshell container, 12-count,…
- Bakery Variety Pack Cookies Containing Oatmeal Rasin Cookies packaged in clear plastic…
- Cookie Platter Containing Oatmeal Rasin Cookies packaged in plastic container, 48-count…
- Dove Chocolate Assortment Snowflakes Net
- Masago Lake Smelt Roe 6 oz
- Dockside Classics 4 Gourmet Lobster Cakes Net Wt
- Dockside Classics 4 Premium Crab Cakes Net Wt
- Guaifenesin Grape liquid 100 mg/5 mL, packaged in 4oz
- Guaifenesin DM Cherry liquid (guaifenesin 100 mg/5 mL and Dextromethorphan HBr 5 mg/5 m…
- Ephedrine Sulfate 5 mg/mL in 0
- Epinephrine (PF) 10 mcg/mL in 0
- Phenylephrine (PF) 100 mcg/mL in 0
- Rocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, P…
- Succinylcholine 20 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx o…
- Midazolam (PF) 0
- Ondansetron 2 mg/mL, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals,…
- Midazolam (PF) 0
- Fentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes a) Total dosage 250 mcg/…
- Morphine Sulfate (PF) 0
- Hydromorphone HCl 1 mg/mL in 0
- Glycopyrrolate 0
- Ketamine 100 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 1mL, Rx only, P…
- Morphine Sulfate (PF) 0
- Ketamine 50 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 1mL, Rx only, PHA…
- Midazolam 1 mg/mL in 0
- Lidocaine HCI (PF) Inj, USP 2%, injectable packed in syringes, Total dosage 100 mg/ 5mL…
- Provocholine Pre-diluted Set II in 0
- Provocholine Pre-diluted Set II in 0
- Provocholine Pre-diluted Set II in 0
- Provocholine Pre-diluted Set II in 0
- Provocholine Pre-diluted Set II in 0
- Levofloxacin Tablets USP, 500 mg, packaged in 100-count (10 x 10) blister cards per car…
- MEROPENEM in NS, Packaged as a) 1000MG in 250ML Homepumps, and b) 2GM in 100ML Homepump…
- CUBICIN (daptomycin) in NS, Packaged as a) 350MG in 7ML Syringes, b)365MG in 7
- SOD CHLORIDE (Sodium Chloride), Packaged in a) 0
- Parenteral Amino Acid Infusion 10%, Packaged in a) 780ML Homepumps, b) 1000ML Homepumps…
- CEFAZOLIN, Packaged as a) 625MG in 6
- Milrinone in 0
- SOLUMEDROL (methylprednisolone succinate) 1GM in NS, Packaged in 100ML Homepumps, Rx Only
- INTRALIPID (fat emulsion), Packaged in a) 27ML Homepumps, b) 125ML Homepumps, c) 1800ML…
- POTASSIUM CHLORIDE in D 5 1/2NS, Packaged in a) 40 mEq KCL/LITER 1000ML Homepumps and b…
- Dextrose-NaCl (D5-1/2NS) in NS, Packaged in a) 1700ML Homepumps, b) 1800ML Homepumps,…
- CEFTRIAXONE in NS, Packaged as a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and…
- DOBUTAMINE HCL in D5W, Packaged as a) 240MG in 60ML Homepumps and b) 1520MG in 380ML Ho…
- VANCOMYCIN HCL, Packaged as: a) 600MG in 120ML Homepumps, b) 750MG in 150ML Homepumps,…
- ONDANSETRON HCL 8MG, Packaged in 100ML Homepumps
- HYDROMORPHONE HCL, Packaged as a) 2
- GANCICLOVIR in NS, Packaged as a) 320MG in 64ML Homepumps and b) 2440MG in 488ML Homepu…
- ASCORBIC ACID 500MG/Syringe, Packaged in 1ML Syringes, Rx Only
- Invanz (ertapenem) Injection Recon Soln in NS, Packaged as a) 500MG in 50ML Homepumps a…
- CEFEPIME, Packaged a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 12GM in…
- ZOSYN (pipericillin/tazobactam) in NS, Packaged as a) 3
- MORPHINE 10MG/ML in NS, Packaged in a) 150ML Homepumps and b) 250ML Homepumps, Rx Only
- PENICILLIN in D5W, Packaged as a)36MU in 360ML Homepumps and b) 51MU in 510ML Homepumps…
- FLUCONAZOLE IN NACL 400MG in NS, Packaged in 200ML Homepumps, Rx Only
- Ampicillin/Sulbactam 12GM in NS, Packaged in 600ML Homepumps, Rx Only
- Nafcillin 2GM in NS, Packaged in 50ML Homepumps, Rx Only
- Lactated Ringers, Packaged in a) 1500ML Homepumps, b) 2800ML Homepumps, and c) 3600ML H…
- Cancidas (caspofungin acetate) 58
- AZACTAM (aztreonam) 2GM in NS, Packaged in 100ML Homepumps, Rx Only
- CLINDAMYCIN 120MG in NS, Package in 20ML Homepumps, Rx Only
- Solu-Cortef (hydrocortisone) 1MG in NS, Packaged in 0
- GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps, and c) 37…
- Tobramycin 120MG, Packaged in 150ML Homepumps, Rx Only
- Dextrose-5% Lactated Ringers, Packaged in 3000ML Homepumps, Rx Only
- MYCAMINE (micafungin sodium) 150MG, Packaged in 150ML Homepumps, Rx Only
- Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (…
- Tropicamide Ophthalmic Solution USP, 0
- Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-585-59…
- Mandarin Oranges (In Light Syrup)
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