Important Recall Notice: Mislabeled Phenobarbital Tablets

Update – March 14, 2011: The original FDA alert regarding this issue contained adverse event reporting information that does not apply to adverse events in animals. Veterinarians with patients that have experienced adverse events should follow the FDA’s standard reporting guidelines for such events. The post below has been updated to reflect this correct reporting information.

Today, the U.S. Food and Drug Administration (FDA) issued a warning to veterinarians about the possibility that phenobarbital tablets produced and labeled as phenobarbital by Qualitest Pharmaceuticals may actually be mislabeled hydrocodone tartrate and acetaminophen tablets.

The company issued a recall of the phenobarbital tablets on February 5, 2011, but the FDA reports that they have recently received reports of severe adverse events associated with the administration of the mislabeled product to pets.

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 Puerto Rico).

If you have any of the affected lots in stock, discontinue use of the product immediately and contact Qualitest at 1-800-444-4011 for reimbursement.  If your patients have experienced any adverse events related to the use of these products, please report the events to the FDA according to their guidelines on adverse event reporting for veterinarians.

6 thoughts on “Important Recall Notice: Mislabeled Phenobarbital Tablets

  1. It is sad that it takes so long for these kind of things to come to the attention of the ones who are ultimately affected. How can these kind of mistakes be prevented and are questions like this being asked to the FDA?

  2. One of my patients ended up in critical care after getting a prescription refill on Saturday. The dog had a complete workup at a neurologist for seizures a year ago, with no known cause found for her seizures. It is unfortunate that such a critical mistake was made.

  3. More information, courtesy of Vet Practice News: 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

    @Hilary – we agree, it’s sad this has happened. Hopefully, the number of pets affected will remain low (although that’s no comfort to the vets or owners of the pets hurt by this). We try to keep track of all recalls that directly or have the potential to affect veterinary medicine, but we’re not notified of all of them. Despite being signed up to receive FDA alerts, we didn’t receive info on the original recall.

  4. Why are veterinarians finding out about this now? The FDA issued an alert on 2/7/11 which is when I first turned to my colleague and said “how long do you think til someone poisons a pet with this stuff?” I’m so sorry to hear it’s actually happened :(