Product Recalls: May 1, 2013 – May 28, 2013
Health Letter, July 2013
This section includes recalls from the Food and Drug Administration (FDA) Enforcement Report for drugs and dietary supplements (www.fda.gov/Safety/Recalls/EnforcementReports/default.htm), and Consumer Product Safety Commission (CPSC) recalls of consumer products.
DRUGS AND DIETARY SUPPLEMENTS
Recalls and Field Corrections: Drugs – Class I
Indicates a problem that may cause serious injury or death
BLUE Diamond Pill, male sexual enhancement pill, 1-, 5- and 10-count blister packs. Volume of product in commerce: 213,000 capsules. Marketed without an approved NDA/ANDA: Product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs. Performance Plus Marketing, Inc.
BLUE Diamond PLATINUM Capsules, 1,000 mg, supplied in 1-, 5- and 10-count blister packs. Volume of product in commerce: 1,000 capsules. Marketed without an approved NDA/ANDA: Product may contain undeclared sildenafil, tadalafil and analogues of these FDA- approved active ingredients, making them unapproved drugs. Multiple lots affected. Contact your pharmacist. Performance Plus Marketing, Inc.
CASANOVA Capsules, 450 mg, male sexual enhancer, supplied in
1-count blister packs. Volume of product in commerce: 96,000 capsules. Marketed without an approved NDA/ANDA: Product may contain undeclared sildenafil, tadalafil and analogues of these FDA-approved active ingredients, making them unapproved drugs.
Lot #: 030112, expiration date 03/15. Performance Plus Marketing, Inc.
Libigrow Capsules, supplied in 1-, 5- and 10- count blister packs. Volume of product in commerce: 610,000 capsules. Marketed without an approved NDA/ANDA: Product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs. Multiple lots affected. Contact your pharmacist. Performance Plus Marketing, Inc.
Libigrow XXXTREME Capsules, MAXIMUM STRENGTH FORMULA, 1,000 mg, supplied in 1-, 5- and 10-count blister packs. Volume of product in commerce: 686,000 capsules. Marketed without an approved NDA/ANDA: Product may contain undeclared sildenafil, tadalafil and analogues of these FDA-approved active ingredients, making them unapproved drugs. Multiple lots affected. Performance Plus Marketing, Inc.
Mojo Nights and Mojo Nights for Her, 1 capsule. Volume of product in commerce: 1,000 blister packs. Marketed without an approved NDA/ANDA: The products were found to contain FDA-approved ingredients and analogues of FDA-approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs. All lots, all expiration dates. Evol Nutrition.
Mojo Nights SUPREME Capsules, 1,000 mg, 1-count blister packs. Volume of product in commerce: 70,000 capsules. Marketed without an approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs. Lot #: 01MJS0712, expiration date 07/15. Performance Plus Marketing, Inc.
Super Power Capsules, Proprietary Blend 570 mg, packaged in 2-count capsules per blister pack. Volume of product in commerce: 40,480 capsules. Marketed without an approved NDA/ANDA: This dietary supplement has been found to contain sildenafil, an FDA approved drug for the treatment of male erectile dysfunction making this an unapproved new drug. Lot #: L08108, expiration date 06/15.
D&S Herbals, LLC.
WOW, Health Enterprises, Dietary Supplement, 30 caplets. Volume of product in commerce: 17,555 bottles. Marketed without an approved NDA/ANDA: Contains undeclared drug ingredients, making it an unapproved drug. FDA sample analysis has found the product to contain methocarbamol, dexamethasone, and diclofenac. All lots, all expiration dates. Brower Enterprises Inc.
Recalls and Field Corrections: Drugs – Class II
Indicates a problem that may cause temporary or reversible health effects; unlikely to cause serious injury or death
Amoxicillin Capsules, USP 500 mg, 500- and 30-count bottles. Volume of product in commerce: 8,286 30-count and 37,108 500-count bottles. Presence of foreign substance: Certain lots of amoxicillin capsules are being recalled due to potential contamination with fragments of stainless steel wire mesh. Multiple lots affected. Contact your pharmacist. Sandoz Inc.
Donnatal Extentabs, 0.3888mg/46.8mg, 100-count bottle. Volume of product in commerce: 1,258 bottles. Labeling: Incorrect or missing lot and/or expiration date: Bottled product is labeled with an expiration date of Apr 2015. The correct expiration is Apr 2013. Lot #: 68864, expiration date 04/13. West-ward Pharmaceutical Corp.
Glimepiride Tablets, USP, 2 mg, 100-count tablets per bottle. Volume of product in commerce: 10,373 bottles. Failed Tablet/Capsule Specifications: One oversized tablet was found in a sealed 100-count bottle of glimepiride at the retail level. Lot #: C0671212A, expiration date 12/14. Qualitest Pharmaceuticals.
Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, 90 count bottles. Volume of product in commerce: 12,770 bottles. cGMP deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices. Lot #s: PA22028, expiration date 5/14; PA22029, expiration date 5/14. Jubilant Cadista Pharmaceuticals Inc.
Pentrexcilina Tablets (acetaminophen, chlorpheniramine maleate and phenylephrine HCl), 20-count tablets per carton. Volume of product in commerce: 11,580 cartons. Labeling: Not elsewhere classified: Pentrexcilina tablets and pentrexcilina liquid are being recalled because the product labels are misleading because they may be confused with pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico. Lot #: 11611B0, Batch # 114039, expiration date 10/14. Distributed by Laboratorios Norimex Co.
Walmart Amlodipine Besylate Tablets, USP 10 mg, 30 tablets. Volume of product in commerce: 484,236 cartons. Labeling: Labeling error on declared strength; Product label incorrectly states amlodipine 5 mg instead of amlodipine 10 mg. Tablet strength is 10 mg. Lot #s: 130251, 130252, 130253, expiration date 11/14. Legacy Pharmaceutical Packaging LLC.
CONSUMER PRODUCTS
Contact the Consumer Product Safety Commission (CPSC) for specific instructions or return the item to the place of purchase for a refund. For additional information from the CPSC, call its hotline at (800) 638-2772. The CPSC website is www.cpsc.gov. Visit www.recalls.gov for information about FDA recalls and recalls issued by other government agencies.
Name of Product; Problem; Recall Information
5-Tray Dehydrator with Digital Timer. The fan can fail, causing the unit to overheat and pose a fire hazard. LEM Products Distribution at (877) 536-7763 or www.lemproducts.com.
Anywhere Lounger Bean Bag Chairs. Bean bag chairs without a permanent zipper closure allow young children to unzip, ingest or inhale the small beads inside of the bean bag chair, posing a suffocation and strangulation hazard. Powell Company at (800) 622-4456 or www.powellcompany.com.
Area Rugs. The rugs fail to meet federal flammability standards, posing a fire hazard to consumers. Nourison at (800) 223-1110 or www.nourison.com.
Children’s Two-Piece Pajama Sets. The pajamas fail to meet federal flammability standards for children’s sleepwear, posing a risk of burn injuries to children. Vive La Fete at (800) 535-7396 or www.vivelafete.com.
Children’s Water Bottles. The water bottle’s spout can break off, posing a choking hazard to children. H&M toll-free at (855) 466-7467 or www.hm.com.
Competition/Closed Course and Enduro Motorcycles. During use, the throttle cable can malfunction and result in an uncontrollable throttle. This poses a crash hazard to the rider. KTM North America Inc. or Husaberg North America toll-free at (888) 985-6090 or www.ktm.com.
Deezo boys and girls zip-up hoodies. The sweatshirts and jackets have drawstrings through the hood which pose a strangulation hazard to young children. Zulily, Inc. at (877) 779-5615 or www.zulily.com.
GNU Snowboard Bindings. The ankle straps can break posing a fall hazard. Mervin Manufacturing at (800) 905-0551 or www.mervin.com.
Insolroll Solar Powered and Rechargeable Motor Roller Shades. The motor of these roller shades has a built-in lithium battery that can overheat while being charged, posing a fire risk. Insolroll at (800) 447-5534 or www.Insolroll.com.
Lea Panel, Loft and Bunk Beds. The bed’s side mattress support rails can break, posing a fall hazard. Lea Industries at (888) 770-7116 or www.leaindustries.com.
Louisville Slugger® OneX Fastpitch Softball Bat. The bat’s barrel can separate from the handle during use and strike people nearby. Hillerich & Bradsby at (800) 282-2287 or www.slugger.com.
Microwave Popcorn Makers. When cooked too long, the popcorn can overheat in this popcorn maker and ignite, posing a fire or burn hazard to consumers. Avon Products at (800) 367-2866 or www.avon.com.
Portable Heaters. The heaters can overheat, posing a fire hazard. Family Dollar Stores at (800) 547-0359 or www.familydollar.com.
Portable Infrared Radiant Quartz Electric Space Heaters. The heater design can fail to prevent ignition of nearby combustible materials that come in contact with the unit, posing a fire hazard to the consumer. Optimus Enterprise Inc. at (888) 672-5832 or www.optimusent.com.
Surly Pugsley Bicycle Forks. The bicycle fork can bend above the disc brake mount, posing a fall hazard to the rider. Surly Bikes at (877) 946-9333 or www.surlybikes.com.
Sweet Lambie Crib Bumper. The thread in the decorative stitching on the bumper can loosen, posing an entanglement hazard to infants. Pottery Barn Kids at (855) 323-5138 or www.potterybarnkids.com.
Teavana Glass Tea Tumblers. The glass tea tumblers can break or shatter unexpectedly, posing laceration and burn hazards. Teavana at (877) 261-1509 or www.Teavana.com.
Toro® Z Master® Riding Mowers. The idler pulley can rub against the mower’s fuel tank, posing a fire hazard. Toro at (855) 493-0090 or www.toro.com.
Touch Point Portable Baseboard Convection Heaters. The heaters can overheat, posing a fire hazard to consumers. Meijer at (800) 927-8699 or www.meijer.com.