The U.S. Food and Drug Administration (FDA) warns veterinarians and pet owners that tablets labeled as phenobarbital may actually be hydrocodone tartrate and acetaminophen tablets. Severe adverse reactions have been reported in pets that were administered the mislabeled pills.
The FDA has published standard reporting guidelines for veterinarians whose patients have been administered the medicine and experienced any adverse events.
The tablets were recalled by the manufacturer, Qualitest Pharmaceuticals, in February of 2011, but adverse reactions in pets are still being reported.
The affected products are Phenobarbital tablets, USP, 32.4 mg, NDC 0603-5166-32 in 1000-count bottles. Affected lot numbers are T150G10B, T120J10E and T023M10A. (The lot numbers are printed on the side of the bottle).
The recalled lots were distributed between Sept. 21, 2010, and Dec. 29, 2010, to wholesale and retail pharmacies nationwide, including in Puerto Rico.
Use of any of these medicines still on pet pharmacy shelves should be discontinued immediately. Reimbursement will be handled by Qualitest at 1-800-444-4011.
