FDA recalls: May 2014
Every food and drug recall report the FDA published in May 2014: 174 reports, 57 of them Class I.
- Recall reports
- 174
- Class I (serious)
- 57
- Food
- 82
- Drugs
- 92
- May 28, 2014BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx only, Teva P…Drug · Teva Pharmaceuticals USAFailed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.Class II
- May 28, 2014BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx only, Teva P…Drug · Teva Pharmaceuticals USAFailed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.Class II
- May 28, 2014Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, IncDrug · Ben Venue Laboratories IncPresence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine SolutionClass I
- May 28, 2014PRO ArthMax Dietary Supplement tablets, 750 mg, 120 count bottles, Distributed by Human…Drug · HUMAN SCIENCE FOUNDATIONMarketed without an Approved NDA/ANDA; FDA analysis found the product to contain Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and IndomethacinClass I
- May 28, 2014Effexor XR (venlafaxine HCl) Extended-Release Capsules, 150 mg, packaged in a) 30-count…Drug · Pfizer Us Pharmaceutical GroupPresence of Foreign Tablets/Capsules: A Pharmacist reported that a bottle of Effexor XR 150 mg capsules contained a single peach colored capsule printed TKN250 which was identified as a Tikosyn (dofetilide) capsule.Class I
- May 28, 2014Esbelin Siloutte Mezcal Herbal con L-Carnitine Suplemento Alimenticio, 30 capsule bottl…Drug · Herbal Give Care LlcMarketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making t…Class I
- May 28, 2014Esbelin Siloutte Te, Suplemento Alimenticio, herbal tea in a gold foil/plastic zip-lock…Drug · Herbal Give Care LlcMarketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making t…Class I
- May 28, 2014Esbelder Siloutte Suplemento Alimenticio, 30 capsule bottle, Hecho en Mexico Por: Herb…Drug · Herbal Give Care LlcMarketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making t…Class I
- May 28, 2014Esbelder Man Herbal Blend With L-Carnitine Dietary Supplement, 30 capsule bottle, Made…Drug · Herbal Give Care LlcMarketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making t…Class I
- May 28, 2014Esbelder Fem Mezcla con L-Carnitina Suplemento Alimenticio,30 capsule bottle, Hecho en…Drug · Herbal Give Care LlcMarketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making t…Class I
- XZONE GOLD, 1 capsule blister 750 mg, Distributed by: XZONE, Orlando, FL
- BOOST ULTRA, sexual enhancement dietary supplement, 12-capsule/bottle
- SEXY MONKEY, 2000 mg, 1 count blister, Distributed by A Herbal Bio, Inc
- MiracleZEN Platinum, 1 pill blister pack, 2000 mg capsule, Distributed by: Power Life D…
- Magic For Men, packaged in 1ct blister pack and 12-pill/bottle, 390 mg Manufactured Fo…
- ExtenZe 600 mg, 30 tablet box, Manufactured for: Biotab Nutraceuticals, Inc
- XZEN PLATINUM, 750 mg, Distributed by: XZEN, Los Angeles, CA
- QVAR¿ (beclomethasone dipropionate HFA), 80mcg Inhalation Aerosol, 50 metered inhalatio…
- PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only
- phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle, Rx only, Manufactured for F…
- Liothyronine Sodium Tablets, USP 5 mcg, Rx Only, a) 100-count bottle NDC 42794-018-02 a…
- P-BOOST Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack and 5, 10,…
- NATURECT Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack and 5, 10…
- Oasis TEARS, Lubricant Eye Drops, 10mL/0
- Bystolic (nebivolol), 20 mg/tablet, 30 tablets per bottle, Rx only, Licensed from Mylan…
- Red Yeast Rice High Potency Dietary Supplement, 600 mg, packaged in a) 120-count VegeCa…
- Verdex Fresh Snow Peas packed in 10 pounds cartons, keep refrigerated
- On cap 100% Spring Water Bottled at Aqua Filter Fresh, Inc
- On cap Purified Water Bottled at Aqua Filter Fresh, Inc
- Bolivian Artichoke Salad sold at Whole Foods 10 lb bulk bags, refrigerated
- Meijer Baby Pediatric Electrolyte Fruit Flavor 8oz x 4 with Best by: 10/01/15
- Meijer Baby Pediatric Electrolyte Strawberry Flavor 8oz x 4 with Best by: 10/02/15
- Stonyfield YoBaby Pear/Peach Organic Whole Milk Yogurt multipack- 6 pack plastic cups-…
- Stonyfield YoBaby Vanilla Organic Whole Milk Yogurt multipack 6 pack plastic cups/4 oz…
- Stonyfield YoToddler Raspberry/Pear Cereal Organic Whole Milk Yogurt with Fruit and Cer…
- "Emparedados Boricua, Pollo & Queso (Chicken & Cheese)
- "Emparedados Boricua, Cubano (Pork, Ham and Cheese Sandwich)
- "Emparedados Boricua, Media Noche (Pork, Ham and Cheese Sandwich)
- "Emparedados Boricua, Tripleta (Turkey Pastrami, Turkey, Ham and Cheese Sandwich)
- Blue Bunny Premium Ice Cream, Bordeaux Cherry Chocolate, 1
- Lipton Pure Leaf Iced Tea Unsweetened 18
- Lipton Pure Leaf Iced Tea Sweet Tea 18
- Lipton Pure Leaf Iced Tea Lemon 18
- Lipton Pure Leaf Iced Tea Lemon 18
- Lipton Pure Leaf Iced NTS Honey Green Tea 12 Pack
- Lipton Pure Leaf Iced NTS Peach Tea 12 Pack
- PDP reads in part "***GOOD FOOD MADE SIMPLE***breakfast in a bowl *** SOUTHWESTERN VEGG…
- METHYLDOPA Tablets USP, 500 mg, 100 count bottle, Rx only, Manufactured In INDIA By: EM…
- GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufac…
- INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By:…
- INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count…
- PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC
- Laroscorbine Platinium (vitamin C/collagen) injectable I
- Tatiomax (reduced glutathione/hydrolyzed collagen) powder for injection vials, 1200 mg/…
- Saluta (reduced glutathione) Powder for Injection, 600 mg/vial, packaged in 10 vials pe…
- Relumins Advanced Glutathione (lyophilized glutathione/vitamin C) injectable solution,…
- Vitamin C (ascorbic acid) Injection, USP, 500 mg per 2 mL, 50 x 2 mL ampoules per box,…
- Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per box, Manu…
- REUMOFAN PLUS Tablets, 30 Tablet Bottles, OTC
- Smart Tab First Aid ezRefill System Ibuprofen dispenser boxes (Item Number FAE 7014), 2…
- Fernandez True Chile Flavor, Medium Hot Chile Molido Puro, 4 oz
- Fernandez True Chile Flavor, Mild Chile Rojo, 6 oz
- Frozen Corkscrew Pasta and Creamy tomato Vodka Sauce meal
- Fresh Express, Italian, Crunchy Romaine Lettuce and Red Cabbage Salad, 10oz clear plast…
- Adult Herbal Blend 992 Item #H039 30 KGS PO#33590 Raw Deal Inc
- Cilantro Powder Item #13151 22
- Parsley Powder Organic 25 KGS PO# GV93-6 & PO#RV19-4 Raw Deal Inc
- Swanson Full Spectrum Cilantro (Coriander) Herbal Supplement, 60 capsules, 425 mg, SW1112
- GOOD TASTE brand Plum, 10
- Soy Bean Cake Net Wt
- Organic Basil 2
- TRADER GIOTTO'S CAESAR SALAD with Caesar Dressing
- Private Selection Chocolate Hazelnut Mascarpone Ice Cream, 16 fl oz lamented carton
- Private Selection Caramel Hazelnut Fudge Truffle Ice Cream, 16 fl oz lamented carton
- 2372 HOT & SPICY
- Kaija Ivasi Lightly Salted Herring Fillets in Oil UPC 3585600709
- Hickory Farms Chipotle Ranch Sauce
- Hickory Farms Farmstand Recipe Chipotle Ranch Sauce Net Weight 9 Ounces
- Deb-El Foods Dried Whole Eggs Deb El Food Products LLC 2 Papetti Plaza, Elizabeth, NJ 0…
- Purity Organic - Organic Mango Mango Tommy Atkins CAT 1, Size 07, 08, 10 and 12
- Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Ma…
- Metformin Hydrochloride Tablets USP 500 mg, 500 tablets Rx Only, Manufactured by Blu Ca…
- Metformin Hydrochloride Tablets USP 1000 mg, 500 tablets Rx Only, Manufactured by Blu C…
- Mangiacotti - Lemon Verbena Hand Sanitizer Spray, alcohol free, 0
- Mangiacotti - Lavender Hand Sanitizer Spray, alcohol free, 0
- Mangiacotti - Ocean Hand Sanitizer Spray, alcohol free, 0
- Mangiacotti - Clementine Hand Sanitizer Spray, alcohol free, 0
- Mangiacotti - Pomegranate Hand Sanitizer Spray, alcohol free, 0
- Mangiacotti - Ginger Lime Hand Sanitizer Spray, alcohol free, 0
- Liptruzet (ezetimibe and atorvastin) tablets,10 mg/10 mg, a) 30 count blister (NDC 6…
- Liptruzet (ezetimibe and atorvastin) tablets,10 mg/20 mg, a) 30 count blister (NDC 6…
- Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg, a) 30 count blister (NDC 6…
- Liptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg, a) 30 count blister (NDC 6…
- Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc
- Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratories, Inc
- Scale label printed with "EASTER BREAD NET WT 17oz (1
- the BREAD STOP Country White Bread 24 oz
- the BREAD STOP Amaranth 24 oz
- the BREAD STOP Oatmeal Bread 24 oz
- the BREAD STOP Honey Wheat Bread 24 oz
- the BREAD STOP Sourdough Bread 24 oz
- the BREAD STOP Wheat Sourdough 24 oz
- the BREAD STOP Flaxseed Bread 24 oz
- the BREAD STOP Spelt and Millet Bread 24 oz
- Bissinger's Dark Chocolate Bunny Ears, 1 oz, individually wrapped in clear plastic with…
- Archer Farms Brand Chocolate Hazelnut Swirl Gelato (Italian Ice Cream), 30 FL OZ
- PRIVATE SELECTION SWEET STRAWBERRY SORBET, Labeled in part: "INGREDIENTS: WATER, SUGAR*…
- Phosphatidylcholine Solution for Injection, 50 mg/ mL, 50 mL Vial, Rx Only, Not for Resale
- Papaverine 60 mg, Phentolamine 4 mg, and Atropine 0
- Polidocanol 1% Solution, 50 mL Vial, Rx Only, Not for Resale
- Polidocanol 3% Solution, 50 mL Vial, Rx Only, Not for Resale
- Sevoflurane, USP (Inhalation Anesthetic), Rx Only, 250 mL Amber Bottle
- Human Chorionic Gonadotropin, EP (HCG) in 5 mu
- Cefoxitin for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog No
- 0.9 % Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB Container,…
- Ceftriaxone for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Cata…
- Cefepime for Injections USP and Dextrose Injection USP, 1 g in Duplex, 50 mL Container,…
- Cefazolin for Injection USP and Dextrose Injections USP, 1 g in Duplex, 50 mL Containe…
- Cefazolin for Injection USP and Dextrose Injection USP, 2 g in Duplex, 50 mL Container…
- 0.9 % Sodium Chloride Injection USP, 1000 mL, Catalog No. S4000-SS, Rx Only, Sterile, S…
- 6.9% FreAmine HBC (Amino Acid Injection), partial fill container 750 mL in a 1000 mL co…
- 15% Amino Acids Injection PBP Glass, 1000 mL, Catalog No
- TrophAmine (10% Amino Acid Injection), 500 mL Container, Rx Only, Catalog No
- ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 mL Contain…
- Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, Catalog No
- Dianeal PD-2 Peritoneal Dialysis Solution with 1
- Adipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle, Dietary Suppl…
- Lidocaine HCl Injection, USP, 2%, 20 mg per mL, packaged in 5-mL single-dose vials, 10…
- Fluoxetine Capsules, USP, 20 mg, 30-count bottles, Rx only, Distributed by: Wal-Mart, B…
- Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b)…
- Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By:…
- 0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufactured by Baxte…
- Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count bot…
- Venlafaxine Hydrochloride Extended-Release Tablets, 37
- Glytone Acne, acne treatment facial cleanser, 2% Salicylic Acid, 200 mL/6
- Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold, Dextromethorp…
- Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit w…
- Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit w…
- LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension) Single Dose Administration K…
- Lupron Depot (leuprolide acetate for depot suspension) Single Dose Administration Kit w…
- Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit w…
- Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by S…
- Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Ma…
- Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl and phenylep…
- Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc
- Losurdo IMPORTED GRATED PECORINO ROMANO
- Holiday Foods, Cheddar Cheese Puffs, 4800308
- Holiday Foods Gourmet Cold Canapes Assortment, 4800361
- Pastene MAFALDINE 5, 16 oz cellophane bag Imported from Italy
- Pastene GEMELLI 104, 16 oz cellophane bag Imported from Italy
- Pastene REGINE 10, 16 oz cellophane bag
- Pastene FARFALLINE 78, 16 oz cellophane bag
- Pastene ITAL TAGLIATELLE VERDI #80, 16 oz cellophane bag
- Pastene ITAL CAPELLI D'ANGELO #83, 16 oz cellophane bag
- Pastene ITALIAN SPAGHETTI #15, 16 oz cellophane bag
- Pastene ITALIAN LINGUINE #6, 16 oz cellophane bag
- Pastene ITALIAN ZITI RIGATI #20, 16 oz cellophane bag
- Pastene ITALIAN FUSILLI #28, 16 oz cellophane bag
- Pastene ITALIAN CAPELLINI #17, 16 oz cellophane bag
- Pastene ITALIAN RIGATONI #31 , 16 oz cellophane bag
- Pastene ITALIAN SHELLS #25 , 16 oz cellophane bag
- Pastene ITALIAN DITALI #45 , 16 oz cellophane bag
- Pastene ITALIAN STELLINE #59 , 16 oz cellophane bag
- Pastene ITALIAN TRIVELLA #69 , 16 oz cellophane bag
- Pastene ITAL NIDI #81 ,16 oz cellophane bag
- Pastene ITALIAN FARFALLE #66 ,16 oz cellophane bag
- Pastene ITALIAN PAPPARDELLE ,16 oz cellophane bag
- Pastene ITALIAN BUCATINI,16 oz cellophane bag
- Pastene ITALIAN ORECCHIETTE ,16 oz cellophane bag
- Pastene ITAL LONG FUSILLI ,16 oz cellophane bag
- Pastene ITAL TRICOLOR FARFALLE ,16 oz cellophane bag
- Pastene ITAL SPIRAL TRI COLOR,16 oz cellophane bag
- Fish Oil Softgel Capsules in white High Density Poly-Ethylene bottles labeled in part:…
- RISING MOON ORGANICS BASIL ASIAGO PINE NUT PESTO RAVIOLI
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