Seizure Drug Warning and Recall: Phenobarbitol

FDA Advises Veterinarians of Recent Recall of Human Drug, Phenobarbitol – Drug is Prescribed for Animals Extralabel

March 10, 2011

The Food and Drug Administration’s Center for Veterinary Medicine (CVM) has become aware of a human drug recall for Phenobarbital tablets. Phenobarbital is prescribed by veterinarians as an extralabel use for treating seizures in animals.

On February 5, 2011, Qualitest Pharmaceuticals voluntarily recalled several lots of Phenobarbital 32.4 mg and Hydrocodone Bitartrate andacetaminophen Tablets 10 mg/500 mg due to a label mix-up between the two drug products. Hydrocodone Bitartrate and Acetaminophen Tablets were incorrectly labeled as Phenobarbital tablets 32.4 mg. As a result of this mix-up, pets may unintentionally be given Hydrocodone and Acetaminophen tablets instead of the intended drug, Phenobarbital.

CVM has recently received 3 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.

Julie Papay, Pharm.D.
GlaxoSmithKline
Safety Evaluation & Risk Management
Global Clinical Safety & Pharmacovigilance
RTP, NC
(919) 483-0119

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