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 and Acetaminophen 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.
Additional Information on the Recall
Qualitest Pharmaceuticals Issues Voluntary, Nationwide Recall Of Hydrocodone Bitartrate And Acetaminophen Tablets, USP 10 MG / 500 MG, NDC 0603-3888-20, 60 Count, Lot Numbers T150G10B, T120J10E And T023M10A And Phenobarbital Tablets, USP 32.4 MG, NDC 0603-5166-32, 1000 Count, Lot Numbers T150G10B, T120J10E And T023M10A[ARCHIVED]