Product Recalls in 2013

5,503 recalls issued this year

290

CPSC

2,420

FDA Food

2,085

FDA Drug

708

NHTSA

FDA Drug Class II Terminated

Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton, Rx only, Manufactured by: Amgen Manufacturing Ltd., a subsidiary of Amgen Inc., Thousand Oaks, CA 91320-1799

September 17, 2013 Amgen, Inc. 4,163 prefilled syringes units
FDA Drug Class II Terminated

Quinapril Tablets USP, 10 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 United States Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-55

September 17, 2013 Lupin Pharmaceuticals Inc. 22, 896 bottles units
CPSC Ongoing

Waterlogic Recalls Water Cooling, Heating Systems Due to Fire Hazard

September 17, 2013 Waterlogic Manufacturing China About 48,000 units
FDA Food Class III Terminated

Fruit Rush Lemon Lime Artificially Flavored Fruit Drink, One Gallon, Plant 06-704

September 17, 2013 Dean Foods, Inc. Unknown units
FDA Food Class III Terminated

Fruit Rush Black Cherry Artificially Flavored Fruit Drink, One Gallon, Plant 06-704

September 17, 2013 Dean Foods, Inc. Unknown units
FDA Drug Class II Terminated

Quinapril Tablets USP, 5 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 United States Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-556

September 17, 2013 Lupin Pharmaceuticals Inc. 30,264 bottles units
CPSC Ongoing

The Children's Place Recalls Footed Pajamas Due to Violation of Federal Flammability Standard

September 17, 2013 About 38,000 in the United States and 3,280 in Canada units
FDA Drug Class II Terminated

Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-451-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-451-56, c)

September 17, 2013 Mylan Institutional, Inc. (d.b.a. UDL Laboratories) a) 42,733 cartons; b) 3,267 cartons; c) 10,303 cartons; d) 4,262,856 cartons units
FDA Drug Class II Terminated

Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-452-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-452-56; an

September 17, 2013 Mylan Institutional, Inc. (d.b.a. UDL Laboratories) a) 11,064 cartons; b) 2,052 cartons; c) 5,567 cartons units
NHTSA Ongoing

Electric Door Actuator May Lead to Fire

September 17, 2013 Eldorado National- Kansas 1,765 units
FDA Food Class III Terminated

Fruit Rush Fruit Punch Artificially Flavored Fruit Drink, One Gallon, Plant 06-704

September 17, 2013 Dean Foods, Inc. Unknown units
FDA Drug Class II Terminated

Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and b) 30-count tablets per dosage card in a carton, NDC 51079-450-63, Rx o

September 17, 2013 Mylan Institutional, Inc. (d.b.a. UDL Laboratories) a) 9,156 cartons; b) 521,310 cartons units
FDA Drug Class II Terminated

Omeprazole Delayed-Release Capsules, USP, 20 mg, Rx Only, 1000 Capsules per bottle, Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA, NDC: 62175-118-43

September 16, 2013 Kremers Urban Pharmaceuticals, Inc. 3867 bottles units
FDA Drug Class II Terminated

Morphine Sulfate Injection, USP, (25mg/mL), 250 mg, 10mL Fill, Single dosage Flip top Vial, (C-II), (NDC 0409-1135-02), Rx Only, Manfactured for Hospira, Inc., Lake Forest, IL 60045 USA.

September 16, 2013 Hospira, Inc. 29,700 vials units
FDA Drug Class I Terminated

1% Lidocaine HCl Injection, USP, 10 mg/mL, NDC 0409-4276-01, Hospira, Inc., Lake Forest, IL 60045.

September 16, 2013 Hospira, Inc. 374,500 vials units
FDA Drug Class III Terminated

Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, packaged in a) 30- count bottle (NDC 0131-3268-32) and b) 90-count bottle (NDC: 0131-3268-46), Rx only, Manufactured by: Kreme

September 16, 2013 Osmotica Pharmaceutical Corp 57857 bottles units
FDA Drug Class II Terminated

Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-6899-01

September 13, 2013 Mylan Pharmaceuticals Inc. 11,701 bottles units
FDA Drug Class II Terminated

Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII, 100 Count Bottles, Rx Only, Manufactured by: Watson Laboratories, Inc. Corona, CA 92880 USA, NDC 0591-0825-01

September 13, 2013 Watson Laboratories Inc 10,615 bottles units
FDA Drug Class II Terminated

Amlodipine Besylate and Benazepril HCl Capsules, 10mg/20mg, in 100 count bottles (NDC# 0378-6898-01) and 500 count bottles (NDC# 0378-6898-05) labeled in part ***Mylan Pharmaceuticals Inc. Morgantown,

September 13, 2013 Mylan Pharmaceuticals Inc. 42,174 bottles units
NHTSA Ongoing

Tail light Failure

September 13, 2013 BMW OF NORTH AMERICA, LLC 134,100 units
FDA Drug Class II Terminated

Amlodipine Besylate and Benazepril HCl Capsules, 10 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-6900-01

September 13, 2013 Mylan Pharmaceuticals Inc. 23,356 bottles units
FDA Drug Class II Terminated

Ifosfamide Injection 1g/20mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC

September 13, 2013 AmeriSource Bergen 49 vials units
FDA Drug Class II Terminated

Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/20 mg, packaged in a) 100-count bottles (NDC 0378-6897-01) and b) 500-count bottles (NDC 0378-6897-05), Rx only, Mylan Pharmaceuticals Inc., Morga

September 13, 2013 Mylan Pharmaceuticals Inc. 60,506 bottles units
FDA Drug Class II Terminated

Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/10 mg, packaged in a) 100-count bottles (NDC 0378-6896-01) and b) 500-count bottles (NDC 0378-6896-05), Rx only, Mylan Pharmaceuticals Inc., Morga

September 13, 2013 Mylan Pharmaceuticals Inc. 30,878 bottles units
FDA Drug Class II Terminated

Amlodipine Besylate Tablets, USP 10 mg, packaged in a) 90-count bottles (NDC 0378-5210-77) and b) 500-count bottles (NDC 0378-5210-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.

September 13, 2013 Mylan Pharmaceuticals Inc. 101,450 bottles units
FDA Food Class II Terminated

Idahoan, Steakhouse Parmesan topping, Net Weight 35 lbs., Item Code ZID800Bulk.

September 13, 2013 Kerry Foods 10,500 lbs. (300 x 35 pound units) units
FDA Drug Class II Terminated

Ciprofloxacin Tablets, USP, 500 mg,100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC 0378-7098-01

September 13, 2013 Mylan Pharmaceuticals Inc. 941,270 bottles units
FDA Drug Class II Terminated

Amlodipine Besylate and Benazepril HCl Capsules, 2.5 mg/10 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC 0378-6895-01

September 13, 2013 Mylan Pharmaceuticals Inc. 4,722 bottles units
FDA Drug Class II Terminated

Amlodipine Besylate Tablets, USP, 2.5 mg, packaged in a) 90-count bottles (NDC 0378-5208-77) and b) 500-count bottles (NDC 0378-5208-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.

September 13, 2013 Mylan Pharmaceuticals Inc. 37,752 bottles units
FDA Food Class I Terminated

Green Leaf Lettuce is sold in bulk cases under "Garre Farms" or "Rossi Farms" brand. There are 24 heads of green leaf lettuce packed in each cardboard box. The Garre Farms brand is labeled in par

September 13, 2013 Garre Farms 498 cases/24 heads of lettuce per case units
FDA Drug Class II Terminated

Ciprofloxacin Tablets, USP, 250 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7097-01

September 13, 2013 Mylan Pharmaceuticals Inc. 521 bottles units
FDA Drug Class II Terminated

Ifosfamide Injection 3g/60 mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC

September 13, 2013 AmeriSource Bergen 60 vials units
FDA Drug Class II Terminated

Amlodipine Besylate Tablets, USP, 5 mg, packaged in a) 90-count bottles (NDC 0378-5209-77) and b) 500-count bottles (NDC 0378-5209-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.

September 13, 2013 Mylan Pharmaceuticals Inc. 167,866 bottles units
FDA Drug Class II Terminated

Lamotrigine Tablets, USP, 200 mg, packaged in a) 60-count bottles (NDC 0378-4254-91) and b) 500-count bottles (NDC 0378-4254-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.

September 13, 2013 Mylan Pharmaceuticals Inc. 28,140 bottles units
FDA Food Class II Terminated

Roasted Salted Mixed Nuts w/ Peanuts, net wt. 12 oz., packed in a clear plastic bag. Ingredients: blanched peanuts, unblanched peanuts, unblanched almonds, unblanched Brazil nuts, unblanched filbe

September 12, 2013 Dutch Valley Food Development Inc.
FDA Food Class I Terminated

St. Marcellin Au lait pasteurise fabrique en Dauphine l'unite: poids net 80ge Fromagerie Qurtet 38470 VINAY

September 12, 2013 Epicure Food Corp. 20 cases (8-80 gm units per case) units
CPSC Ongoing

Gree Recalls 12 Brands of Dehumidifiers Due to Serious Fire and Burn Hazards; More Than $2 Million in Property Damage Reported

September 12, 2013 Gree Electric Appliances, of China About 2.2 million in the United States and 52,500 in Canada units
FDA Food Class I Terminated

Schwebel's Golden Rich Bun with Honey, 18 oz plastic bag, 12 count, UPC 0 71319 00083 8 Product labeled in part, "INGREDIENTS: ENRICHED WHEAT FLOUR***CONTAINS: WHEAT, SOY SCHWEBEL BAKING CO. YOUNGSTOW

September 12, 2013 Schwebel Baking Company 12,642/18 oz/12 count plastic bags units
CPSC Ongoing

Ceiling-Mounted Light Fixtures Recalled by Dolan Designs Due to Fire and Shock Hazards

September 12, 2013 Dongguan Young Long Electric Co. Ltd. About 8,000 units
FDA Food Class II Terminated

Honey Roasted Peanuts, net wt. 11 oz.., packed in a clear plastic bag. Ingredients: peanuts, sugar, peanut and/or canola and/or cottonseed oil, honey, salt, modified potato starch, xanthan gum. A

September 12, 2013 Dutch Valley Food Development Inc.
FDA Drug Class II Terminated

Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560 NDC 50458-306-11

September 11, 2013 Janssen Pharmaceuticals, Inc. 70,495 kits units
CPSC Ongoing

Visonic Recalls Amber Personal Emergency Response System Kits Due to Remote Pendant Battery Signal Failure

September 11, 2013 Visonic Ltd., of Tel Aviv, Israel About 24,000 units
CPSC Ongoing

Hachette Book Group Recalls Children's Books Due To Choking and Laceration Hazards

September 11, 2013 About 70,000 units
CPSC Ongoing

L.L.Bean Recalls Boat Carts for Canoes and Kayaks; Plastic Wheel Rims Can Burst and Injure Users

September 11, 2013 About 2,200 units
CPSC Ongoing

Cambridge Metal & Plastics Recalls Motorcycle Training Wheels Due to a Crash Hazard

September 11, 2013 Cambridge Metals & Plastics, a Division of Water Works Manufacturing Inc., of Cambridge, Minn. About 4,000 units
FDA Drug Class III Terminated

Loratadine 24 HR-OTC,10 mg, 30-count bottle, Manufactured by Novartis Consumer Health, Parsippany, NJ 07054, Distributed by Physicians Total Care, Tulsa OK 74146, NDC 54868-5268-00

September 11, 2013 Physicians Total Care, Inc. 7,740 pills units
FDA Food Class I Terminated

Bean & Cheese Burrito Filling, 10 lb bags Labeled in part "13210 B 1 77220 13:38 KEEP FROZEN BEAN & CHEESE BURRITO FILLING***INGREDIENTS: COOKED PINTO BEANS, WATER, CHEDDAR CHEESE***SOYBEAN OIL***STAR

September 11, 2013 JTM Provisions Co Inc 821 cases/3/10 lb bags units
NHTSA Ongoing

Battery Equalizers/DC-DC Converters-Possible Fire

September 11, 2013 Sure Power, Inc. 10,989 units
NHTSA Ongoing

Panel Glue/FMVSS 221

September 10, 2013 CORP. MICRO BIRD, INC. 14 units
FDA Food Class III Terminated

Sugar free cake: Vanilla flavor. Package size: 4 oz, 12 oz; Sliced Sugar-free cake: Vanilla flavor 16 oz.

September 10, 2013 Cakes & More Delight's 500 boxes total (12 units each) units