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Health Letter Cumulative Alphabetical Subject index

View a comprehensive list of subjects covered in Health Letter from its first issue in 1985 through the present.

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Product Recalls

May 29, 2013 – June 24, 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

MAXILOSS Weight Advanced, 225 mg proprietary blend of herbs, supplied in 36-count capsules per each green and blue box. Volume of product in commerce: 600 boxes. All lots, all expiration dates. Marketed without an approved NDA/ANDA: Product contains sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug. OLAAX International.

Rugby Natural Iron Supplement, ferrous sulfate, 5 gr (325 mg), 100 tablets. Volume of product in commerce: 19,944 bottles. Lot #: 12G468, expiration date 07/2014. Label mixup: Bottles of ferrous sulfate actually contain meclizine HCl (indicated for motion sickness). Advance Pharmaceutical 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

Levothroid (levothyroxine sodium tablets). Multiple dosages, multiple lots, multiple expiration dates. Contact your pharmacist. Volume of product in commerce: unknown. cGMP deviations: After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. Lloyd Inc. of Iowa.

Levoxyl (levothyroxine sodium) tablets. Multiple dosages, multiple lots, multiple expiration dates. Contact your pharmacist. Volume of product in commerce: unknown. Subpotent drug: The products were below specification for potency at the expiry stability point. King Legacy, a wholly owned subsidiary of Pfizer.

Lloyd Thyro-Tab. Multiple dosages, multiple lots, multiple expiration dates. Contact your pharmacist. Volume of product in commerce: unknown. cGMP deviations: After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. Lloyd Inc. of Iowa.

Metronidazole Tablets, USP, 500 mg, multiple pills-per-bottle counts. Multiple dosages, multiple lots, multiple expiration dates. Contact your pharmacist. Volume of product in commerce: unknown. Failed tablet/capsule specifications: Some tablets had the potential to not conform to weight specifications. Physicians Total Care, Inc.

Ropinirole Hydrochloride Tablets, USP 4 mg, 100-count bottle. Volume of product in commerce: 3,048 bottles. Lot #: ZRMB11004, expiration date 09/13. Labeling: Label error on declared strength. Unopened bottles of ropinirole USP 3 mg tablets were found to be incorrectly labeled as ropinirole USP 4 mg tablets. Mylan Pharmaceuticals Inc.

The following over-the-counter medications manufactured by TG United, Inc., have been recalled due to cGMP deviations. These products are underdosed or have an incorrect dosage regime:

AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl. oz. bottle
AMBI 3BRM/15DM/30PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl. oz. bottle
AMBI 3BRM/30DM/50PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl. oz. bottle
AMBI 12.5 CPD/100GFN/30PSE, Antitussive, Expectorant, Nasal Decongestant, Raspberry Flavor, 16 fl. oz. bottle
AMBI 12.5 CPD/120GFN/5PEH, Cough Suppressant, Expectorant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl. oz. bottle
AMBI 15DM/100GFN/5PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 4 fl. oz. bottle
AMBI 20DM100GFN10PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 16 fl. oz. bottle
AMBI 25DPH/7.5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl. oz. bottle
AMBI 25CPD/200GFN, Antitussive, Expectorant, Berry Vanilla Flavor, 16 fl. oz. bottle
AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, 100 count bottle
AMBI 40PSE/400GFN, 100-tablet bottle
Brompheniramine/Pseudoephedrine DM, Antihistamine, Cough Suppressant, Decongestant, 16 fl. oz. bottle
BroveX PSE, Antihistamine, Nasal Decongestant, 100-count bottle
BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100-count bottle
BroveX PSB Liquid, Antihistamine, Decongestant
BroveX PSB DM Liquid, Antihistamine, Decongestant
Cardec DM Drops, Decongestant, Antihistamine, Antitussive, 1 fl. oz. bottle
Cardec Drops, Antihistamine, Nasal Decongestant, 1 fl. oz. bottle
CPM / PSE Drops, Antihistamine, Nasal Decongestant, 1 fl. oz. bottle
CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl. oz. bottle
Dallergy Chewable Tablets, Antihistamine, Nasal Decongestant, 100-count bottle
ED A-HIST Tablets, Antihistamine, Nasal Decongestant, 100-count bottle
Lusair Liquid, 1 pint bottle
Maxifed DM, Expectorant, Nasal Decongestant, 100-count bottle
Maxifed-G, Expectorant, Nasal Decongestant, 100-count bottle
Mesehist DM, Antihistamine, Antitussive, Decongestant, 16 fl. oz. bottle
Mesehist WC, Antihistamine, Antitussive, Decongestant, 16 fl. oz. bottle
NoHist Tablets, Antihistamine, Nasal Decongestant, 100-count bottle
Poly Hist Forte, Nasal Decongestant, Antihistamine, 100-count bottle
Poly-Vent DM Tablets, Cough Suppressant, Expectorant, Nasal Decongestant, 60-count bottle
Poly-Vent IR, Poly-Vent DM Tablets, Expectorant, Nasal Decongestant, 60-count bottle
Ryddex G Tablets, Decongestant, Expectorant, 100-count bottle
TG 40PSE/400GFN Tablets, 1,000-count bottle
TL-DEX DM, Cough Suppressant Decongestant, Expectorant 16 fl. oz. bottle
TL Hist DM, Antihistamine, Decongestant, Cough Suppressant, 16 fl. oz. bottle
TL-Hist PD Drops, Antihistamine, Nasal Decongestant,1 fl. oz. bottle
Tri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant, 16 fl. oz. bottle
Trigofen Drops, Antihistamine, Decongestant,1 fl. oz. bottle
Trigofen DM Drops, Antihistamine,Cough Suppressant, Decongestant, 1 fl. oz. bottle
Z-Dex Pediatric Drops, Cough Suppressant Decongestant, Expectorant 16 fl. oz. bottle
Z-Dex Syrup, Decongestant, Antitussive, Expectorant, 16 fl. oz. bottle
ZoDen DM Drops, Antihistamine,Cough Suppressant, Decongestant, 1 fl. oz. bottle
ZoDen PD, Antihistamine, Nasal Decongestant,16 fl. oz. bottle

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

Aztec Light Chandeliers. The fixture loop that connects the hanging chain to the lamp can fail during use, causing the chandelier to fall from the ceiling and injure bystanders. Kichler Lighting’s Home Center Division (Aztec) at (800) 554-6504 or www.kichler.com.

Baby Bath Seats. The bath seats fail to meet federal safety standards, including the requirements for stability. Specifically, the bath seats can tip over, posing a risk of drowning to babies. BeBeLove at (888) 464-1218 or www.bebeloveusa.com.

Cedar Lake Propane Heater/Cooker. The regulator on the heater/cooker malfunctions when a user switches from a cooking to heating option, or vice versa, the gas propane turns to liquid, which can flare easily and pose a fire hazard. Texsport at (800) 231-1402 or www.texsport.com.

DiveAlert and DiveAlert PLUS Signaling Devices. The signaling device can malfunction when used and restrict the diver’s air flow, posing a drowning hazard. DiveAlert at (800) 275-4332 or www.divealert.com.

Easton Axis Arrows. The arrows can break when fired and hit unintended targets, including the user and bystanders. Easton Technical Products at (888) 380-6234 or www.axisrecall.com.

Gerber® Bear Grylls Parang Machete with Stitched Sheaths. The Parang machete can cut through the stitching of the sheaths when the blade is taken from or replaced in the sheath, posing a laceration hazard. Gerber Legendary Blades at (877) 314-9130 or
www.gerbergear.com.

Idea Baby Bath Seats. The bath seats fail to meet federal safety standards, including the requirements for stability. Specifically, the bath seats can tip over, posing a risk of drowning to babies. Chelsea & Scott at (866) 271-4536 or www.onestepahead.com, and Buy Buy Baby at (877) 328-9222 or www.buybuybabycom.

Jeep Liberty Strollers. The inner tube of the tire on the stroller can rupture, causing the wheel rim to fracture and fly off as a projectile, posing a risk of bodily injury and property damage. Kolcraft at (800) 453-7673 or www.Kolcraft.com.

“Joanna” Girl’s Sandal. The metal flower on the shoe can detach, posing a choking hazard. Stride Rite at (800) 365-4933 or www.striderite.com.

LYDA Jumbo Cups. The cups can break when hot liquid is poured into them, posing a burn hazard. IKEA at (888) 966-4532 or www.ikea-usa.com.

Metal Halide Lamps. The internal wiring can arc, causing the lamp to catch fire or the glass to shatter. This poses fire and laceration hazards. Philips Lighting Company at (800) 372-3331 or www.philips.com/recall.

Paddywax Fragrance Diffusers. The label on the diffusers violates the Federal Hazardous Substances Act (FHSA) by omitting the presence of petroleum distillates. Petroleum distillates pose an aspiration hazard if swallowed. Paddywax at (888) 442-3088 or www.paddywax.com.

Portfolio and Transglobe Nine-Light Chandeliers. The mounting loop that holds the chandeliers to the ceiling can break, causing the chandelier to fall, posing an impact injury hazard to consumers. Bel Air Lighting at (888) 803-0509 or www.regcen.com/belair.

Salsa Bicycle Forks. The bicycle fork can bend above the disc brake mount, posing a fall hazard to the rider. Salsa Cycles at (877) 774-6208 or www.salsacycles.com.

Target-Mins™ Iron Supplement Bottles. The packaging is not child-resistant as required by the Poison Prevention Packaging Act. The supplement tablets inside the bottle contain iron, which can cause serious injury or death to young children if multiple tablets are ingested at once. Country Life at (800) 645-5768 or www.countrylifevitamins.com.

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