Health Letter, October 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
Lightning Rod Capsules, 500 mg/capsule, packaged in 3-count and 12-count bottles. Volume of product in commerce: unknown. No lot information provided. Marketed without an approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of sildenafil. Sildenafil is the active ingredient in an FDA-approved product indicated for the treatment of male erectile dysfunction (ED), making this product an unapproved new drug. Chang Kwung Products.
Night Bullet Capsules, 1-count packets. Volume of product in commerce: 429,619 capsules. Lot #: B43N032, expiration date 10/2015. Marketed without an approved NDA/ANDA: Product contains analogues of sildenafil and tadalafil, which are active pharmaceutical ingredients in FDA-approved drugs used to treat erectile dysfunction (ED), making this product an unapproved new drug. Green Planet Inc.
Reumofan Plus, 30 tablets per bottle. Volume of product in commerce: 586 bottles. Lot #: 99515, expiration date 09/2016. Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients diclofenac sodium, dexamethasone and methocarbamol. Reumofan Plus USA.
Warfarin Sodium Tablets, USP 2 mg. Volume of product in commerce: 960 bottles. Lot #: MM5767, no expiration date provided. Failed tablet/capsule specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1,000-count bottle were oversized. Zydus Pharmaceuticals USA 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
Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet. Volume of product in commerce: 188,680 capsules. Lot #: F1002, expiration date 12/2013. Failed impurities/degradation specifications: Unspecified degradation product. Warner Chilcott US LLC.
Ethambutol Hydrochloride Tablets, USP 400 mg, 60 tablets. Volume of product in commerce: 118 bottles. Lot #: 69968B, expiration date 03/2014. Discoloration: Out-of-specification result for description testing for a surface defect of ink. West-Ward Pharmaceutical Corp.
Excedrin Extra Strength (acetaminophen 250 mg,aspirin (NSAID) 250 mg and caffeine 65 mg), a) 2-count tablets in pouches, b) boxes of 50/2-count package. Multiple lots, multiple expiration dates. Defective container: Products are packaged in pouches that may not have been fully sealed. Novartis Consumer Health.
Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), 2-count tablets packaged in pouches. Multiple lots, multiple expiration dates. Defective container: products are packaged in pouches that may not have been fully sealed. Novartis Consumer Health.
Lisinopril Tablets, USP 2.5 mg. Volume of product in commerce: 51,704 bottles. Multiple lots, multiple expiration dates. Failed impurities/degradation specifications: Out-of-specification results for individual other unknown related Compounds were obtained at the 48 month time-point. West-Ward Pharmaceutical Corp.
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 30 mg and 40 mg, 100-count bottle. Volume of product in commerce: unknown. Multiple lots, multiple expiration dates. Failed dissolution specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing. Teva Pharmaceuticals USA, Inc.
No Doz, Max Strength (200 mg caffeine) caplets, 2-count caplets per pouch. Volume of product in commerce: 4,422,000 pouches. Multiple lots, multiple expiration dates. Defective container: Products are packaged in pouches that may not have been fully sealed. Novartis Consumer Health.
Olanzapine Tablets, USP, 10 mg. Volume of product in commerce: 18,721 bottles. Lot #: BS392004A, expiration date 09/2014. Defective container: This action is being taken as a precautionary measure due to the product being re-packaged in the U.S. using a filler material that removes or blocks less moisture than what is approved in the application. Torrent Pharma Inc.
Parsel Plus (reference U.S. product: Excedrin Tension Headache) (acetaminophen 500 mg and caffeine 65 mg), packaged in 2-count pouches. Volume of product in commerce: 472,000 pouches. Lot #: 10121996, expiration date 07/2013. Defective container: Products are packaged in pouches which may not have been fully sealed. Novartis Consumer Health.
Terazosin Hydrochloride Capsules,10 mg, 100-count bottle. Volume of product in commerce: 6,267 bottles. Lot #: N07321, expiration date 06/2014. Label error on declared strength: Unopened, sealed bottle of terazosin hydrochloride (HCl) 10 mg capsules contained terazosin HCl 5 mg capsules. Teva Pharmaceuticals USA, Inc.
Zolpidem Tartrate Tablets, 5 mg, 10 tablets per blister, 10 blisters per carton, 100 cartons per box. Volume of product in commerce: 48,230 carton units. Multiple lots, multiple expiration dates. Unit dose mispackaging: This recall event is due to a random undetected packaging issue that could increase the potential for a small number of individual unit dose blisters to be packed with more than one tablet. American Health Packaging.
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
Black & Decker® Spacemaker™ 12-Cup Programmable Under-the-Cabinet Coffeemakers. The coffee pot handle can break, causing cuts and burns to the consumer. Applica Consumer Products at (866) 708-7846 or www.aprecall.com.
Char-Broil® Gas Patio Bistro® Grills. The electronic ignition on the grill can ignite unexpectedly, posing a burn hazard. Char-Broil at (866) 671-7988 or www.charbroil.com.
Children’s Pajamas and Nightgowns. The pajamas fail to meet federal flammability standards for children’s sleepwear, posing a risk of burn injuries to children. Klever Kids at (855) 553-8375 or www.shopkleverkids.com.
Endura and Ambient LED Dimmable Light Bulbs. A lead wire in the bulb’s housing can have an improper fitting, which can electrify the entire lamp and pose a shock hazard. Philips Lighting Co. at (800) 295-5147 or www.recall.philips.com.
Giant Bicycle XtC Bicycles and Seatposts. The bicycle seatposts on the affected bicycles and the after-market seatposts can crack, posing a fall hazard. Giant Bicycle Inc. at (866) 458-2555 or www.giant-bicycles.com-en-us/.
Holgate Toys Playmat Sets. The wheels on the wooden vehicles can detach, posing a choking hazard to young children. Holgate Toys at (855) 344-7488 or www.holgatetoy.com.
Husqvarna Closed Course/Competition Off-Road Motorcycles. The motorcycle’s throttle cable can malfunction so the rider loses speed control, posing a crash hazard. Husqvarna Motorcycles at (888) 985-6090 or www.husqvarna-motorcyclesna.com.
Ikea Kritter and Sniglar Junior Beds. The metal rod connecting the guard rail to the bed frame can break in use, posing a laceration hazard. IKEA at (888) 966-4532 or www.ikea-usa.com.
Light-Up Toy Frogs and Ducks. The metal conductor pin on the bottom of the toys can come out, posing a choking hazard. Toysmith at (800) 356-0474 or www.toysmith.com.
Sleepharmony Metal Youth Beds. The surface paint on the pink-colored youth beds contains levels of lead that exceed the limits allowed by law. Glideaway at (800) 428-5222 or www.glideaway.com/recall/.
Sulley Character Stuffed Animal. The stuffed animal’s eye can detach, posing a choking hazard to young children. Build-A-Bear at (866) 236-5683 or www.buildabear.com.
Tabletop Torches. Once lit, the glass citronella table torches can flare up and emit burning lamp oil onto consumers and property, posing fire and burn hazards. Big Lots at (866) 244-5687 or www.biglots.com.