Label Mix-Up Prompts Recall Of Human Drug Prescribed For Animals Extralabel

FDA announce recall of drug originally designed to treat seizures in animals.

The. U.S. Food and Drug Administration’s Center for Veterinary Medicine today warned veterinarians about a recent human drug recall for Phenobarbital tablets. The drug is prescribed by veterinarians as an extralabel use for treating seizures in animals.

The voluntary recall was first announced by Qualitest Pharmaceuticals in early February and involved several lots of Phenobarbital 32.4 mg and Hydrocodone Bitartrate and Acetaminophen Tablets 10 mg/500mg due to a label mix-up between the two drug products.

As a result, pets may unintentionally be given Hydrocodone and Acetaminophen tablets instead of the intended drug, Phenobarbital, according to the Center for Veterinary Medicine.

The recall includes the following products:

• Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg/500mg, NDC 0603-3888-20, 60 count, Lot Numbers T150G10B, T120J10E and T023M10A
• Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1,000 count, Lot Numbers T150G10B, T120J10E and T023M10A

These lots were distributed between Sept. 21, 2010 and Dec. 29, 2010 to wholesale and retail pharmacies nationwide, including Puerto Rico. Lot numbers can be found on the side of the bottle.

Qualitest Pharmaceuticals, a wholly owned subsidiary of Endo Pharmaceuticals, gave descriptions of each drug: Hydrocodone Bitartrate and Acetaminophen Tablets are large (about 16.5 mm in length), pink, capsule-shaped tablets, debossed (3600) on one side and debossed (V) on the reverse side.

Phenobarbital Tablets are small (about 6.4 mm in diameter), white, round, biconvex, scored tablets, debossed (5012) and (V) on one side and plain on the reverse side.

The Center for Veterinary Medicine said it has received three serious adverse event reports involving dogs treated with Phenobarbital tablets manufactured by Qualitest Pharmaceuticals. One report cited two of the three affected lot numbers for the recalled product. The remaining two reports did not provide the lot numbers.

Questions can be directed to Qualitest Pharmaceuticals at 800-444-4011.


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