Product Recalls in 2013

5,503 recalls issued this year

290

CPSC

2,420

FDA Food

2,085

FDA Drug

708

NHTSA

CPSC Ongoing

Avon Recalls Microwave Popcorn Maker Due to Burn and Fire Hazards; New Instructions Provided

May 16, 2013 Okay Enterprise Co., Ltd., of Kunshan City, Taiwan About 54,700 units
FDA Drug Class II Terminated

Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12

May 16, 2013 Hospira, Inc. 95,700 vials units
FDA Food Class I Terminated

Solbar Q Soy Protein Isolates. Item No. / Item Description: 22843 / Solbar Q 843 GMO, 22910 / Solbar Q 910 GMO, 22942 / Solbar Q 842 GMO, 22943 / Solbar Q 842 NGMO, 3323912 / Solbar Q 910, 3323920 /

May 16, 2013 Chs Inc 1,671,960 kilograms units
FDA Food Class II Terminated

Eco-Cuisine English Scone Mix, SKU: AA01SCON, Pack size 1 lb bag, 10 bags per case, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO.

May 16, 2013 Eco-Cuisine 1,005 lbs units
FDA Drug Class II Terminated

Proplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 435mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132

May 15, 2013 Pentec Health 4 Bags units
FDA Drug Class III Terminated

Maximum Strength Comtrex ,Severe Cold & Sinus Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime

May 15, 2013 Novartis Consumer Health 167,712/24-caplet packages units
FDA Drug Class III Terminated

Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg,Phenylephrine HCL 5mg, packaged in 24 coated caplets nighttime formula

May 15, 2013 Novartis Consumer Health 32,256/24-caplet packages units
FDA Drug Class II Terminated

Baxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1000mL bag, b) 2000mL bag, c) 2500mL bag, d) 5000mL bag, and e) 6000mL bag, Pen

May 15, 2013 Pentec Health 8 Bags units
NHTSA Ongoing

Unexpected Unfurling of the Awning

May 15, 2013 GULF STREAM COACH INC. 27 units
FDA Drug Class II Terminated

Baxter LL bag 2% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 2500mL bag and b) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothw

May 15, 2013 Pentec Health 3 Bags units
FDA Drug Class III Terminated

Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit dose (3 x 10 capsules blister packaged) per box, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 265

May 15, 2013 Mylan Institutional, Inc. (d.b.a. UDL Laboratories) 1,621 boxes units
FDA Drug Class III Terminated

Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 caplets. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2062-02.

May 15, 2013 Novartis Consumer Health 2,978,000/2-caplet packages units
FDA Drug Class II Terminated

Proplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 385mL and b) 390mL, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132

May 15, 2013 Pentec Health 9 Bags units
FDA Drug Class II Terminated

Proplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 485mL bag and b) 490mL bag, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3

May 15, 2013 Pentec Health 25 Bags units
FDA Drug Class II Terminated

Baxter LL bag 1% Amino Acids w/KCL (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids and KCL), in 3000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA

May 15, 2013 Pentec Health 1 Bag units
FDA Drug Class III Terminated

Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in a) 8 coated caplets (NDC 0067-6438-08) b) 24 coated caplets (NDC 0067-64

May 15, 2013 Novartis Consumer Health 98,024/8-caplet packages and 557,548/24-caplet packages units
FDA Food Class I Terminated

GRATED 2/25 GRANA PADANO; Lot Code: 313701A01; Pack Size: 2/25#; Net Pounds: 50; PACK DATE: 05/18/13; ITEM#DGP03; arthur schuman inc, 40 new dutch lane fairfield nj 07004 U.S.A.; 937-227-0030 www.arth

May 15, 2013 Arthur Schuman Midwest LLC 2,500 lbs. units
NHTSA Ongoing

Electrical Wiring may not be Secured

May 15, 2013 GULF STREAM COACH INC. 126 units
FDA Food Class III Terminated

ORIGINAL BRAND Arizona SOUTHERN STYLE UNSWEETENED Brewed Tea, Net Wt. 128 FL.OZ (1 GAL.). Product is packaged in a cardboard case, each case contains four 1 Gallon plastic containers. UPC Code: 6 13

May 15, 2013 Arizona Beverages USA LLC 10,286 cases (4 containers per case) units
FDA Drug Class II Terminated

Proplete 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 710mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132

May 15, 2013 Pentec Health 1 Bag units
FDA Food Class II Terminated

Enzyme Solutions, A Dietary Supplement, Formula 29, 8 oz. (226.8g), UPC Code 697706041408. Distributed by: Enzyme Formulations, Inc., Madison, Wisconsin, 53719.

May 15, 2013 Enzyme Formulations, Inc. 256 bottles units
FDA Drug Class II Terminated

IDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), a) 490mL bag, b) 500mL bag, and c) 590mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-31

May 15, 2013 Pentec Health 3 Bags units
FDA Drug Class III Terminated

Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold, Acetaminophen 325mg , Chlorpheniramine Maleate 2mg , Dextromethorphan HBr 10mg , Phenylephrine HCL 5mg, a) 8 coated caplets (NDC 0067-64

May 15, 2013 Novartis Consumer Health 3,768/8-caplet packages and 300,580/24-caplet packages units
FDA Drug Class II Terminated

Proplete 60 - 69 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in 555mL bag, Pentec Health Inc, 4 Creek Parkway Suite A Boothwyn, PA 19061-3132

May 15, 2013 Pentec Health 59 Bags units
CPSC Ongoing

Optimus Recalls Portable Electric Heaters Due to Fire Hazard

May 15, 2013 Dongguang Hong-Hwa Electric Co. Ltd. About 355,000 units
FDA Drug Class II Terminated

Proplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and sterile water), in 330mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-13132

May 15, 2013 Pentec Health 1 Bag units
FDA Drug Class II Terminated

Baxter Ultrabag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1500mL and b) 3000mL bags. Pentec Health Inc., 4 Creek Parkway Suite A, Booth

May 15, 2013 Pentec Health 3 units units
FDA Drug Class III Terminated

Maximum Strength Comtrex , Day/Night Flu Therapy , Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula a

May 15, 2013 Novartis Consumer Health 38,856/24-caplet package units
NHTSA Ongoing

Flip Seat/Possible Toe or foot pinch

May 15, 2013 BLUE BIRD BODY COMPANY 441 units
FDA Drug Class II Terminated

Proplete 90+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 805mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132

May 15, 2013 Pentec Health 1 Bag units
FDA Drug Class II Terminated

Proplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 635mL bag and b) 660mL bag, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-313

May 15, 2013 Pentec Health 38 Bags units
FDA Drug Class II Terminated

Baxter LL bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 3000mL bag, b) 5000mL bag and c) 6000mL bag, Pentec Health Inc., 4 Creek Parkway

May 15, 2013 Pentec Health 5 Bags units
FDA Drug Class III Terminated

Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg, Phenylephrine HCL 5mg, packaged in 16 coated caplets daytime formula an

May 15, 2013 Novartis Consumer Health 104,328/32-caplet packages units
FDA Drug Class II Terminated

HEALTH & BEYOND DR. LARRY'S Tranquility DIETARY SUPPLEMENT 30 Capsules Manufactured for: Health & Beyond 7050 W Palmetto Pk Rd Boca Raton, FL 33433.

May 15, 2013 Health & Beyond 46 bottles units
FDA Drug Class II Terminated

Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. Manufactured by VistaPharm, Inc., Birmingham, AL 35242. Distributed by Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28

May 15, 2013 Actavis South Atlantic LLC A total of 133,968 bottles (units) units
NHTSA Ongoing

Wheelchair Lift Armored Cable Short Circuit

May 15, 2013 STARCRAFT BUS 169 units
FDA Drug Class II Terminated

Fresenius bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), 1000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132

May 15, 2013 Pentec Health 1 Bag units
NHTSA Ongoing

Steering Column Disengagement

May 14, 2013 SUBARU OF AMERICA, INC. 5,379 units
NHTSA Ongoing

Possible Partial Loss of Brake Function

May 14, 2013 MACK TRUCKS, INC 5,203 units
NHTSA Ongoing

Jib Attachment Bracket may Fail

May 14, 2013 ALTEC INDUSTRIES INC. 56 units
NHTSA Ongoing

Brake Master Cylinder Fluid Indicator Switch

May 14, 2013 DORMAN PRODUCTS, INC. 7 units
NHTSA Ongoing

Possible Tie Rod Failure

May 14, 2013 MASERATI NORTH AMERICA, INC. 7,438 units
FDA Drug Class I Terminated

Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534,

May 13, 2013 Zydus Pharmaceuticals USA Inc 960 Bottles units
FDA Drug Class III Terminated

Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Sciences, LLC, Lenoir, NC, Dist. by: West-ward Pharmaceutical Corp., Eatontown, NJ --

May 13, 2013 West-ward Pharmaceutical Corp. Lot PLNJ1201 -16,880 vials ; Lot PLNJ1202 - 16,960 vials units
NHTSA Ongoing

Auxiliary Pump may Overheat Resulting in Fire

May 13, 2013 Elgin Sweeper Company Inc. 15 units
NHTSA Ongoing

Unexpected Unfurling of the Awning

May 13, 2013 FLEETWOOD RV, INC. 196 units
NHTSA Ongoing

Engine Compartment Short Circuit/Possible fire

May 13, 2013 SETRA OF NORTH AMERICA 234 units
NHTSA Ongoing

Possible Loss of Trailer Brakes

May 13, 2013 New Heights LLC 4 units
FDA Drug Class I Terminated

Trace Mineral-5 MDV, supplied in 10 mL vials, Each ML contains: 1 mg Zinc (as sulfate), 0.4 mg Copper (as sulfate), 0.1 mg Manganese (as sulfate), 4 mcg Chromium (as chloride), 20 mcg Selenium (as sod

May 13, 2013 Abrams Royal Pharmacy 21 vials units
FDA Food Class II Terminated

Sara Lee Hearty & Delicious 100% Whole Wheat 8 Bakery Buns Sara lee, Downers Grove, IL 60515

May 10, 2013 BIMBO Bakeries USA 1079 units