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Phenobarb Recall

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I didn't see it here, but I didn't look very hard. if it's a duplicate post, please delete :)


FDA Advises Veterinarians of Recent Recall of 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 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.



Hydrocodone Bitartrate and Acetaminophen 10/500 is what is known as Vicodin or Lortab, and is used for pain relief for people, often post surgery. It is a very strong pain medication, and the amout of acetaminophen would be extraordinarily high for a dog. If you give Phenobarbital, please check your pills. And, pass along to others that use this medication.


ETA: found some lot numbers and stuff off of a different web site

The affected lots were distributed nationwide to retail and wholesale pharmacies between Sept. 21 and Dec. 29, 2010 and include:


• Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, 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.


Consumer who purchased the affected lots should contact Qualitest at (800) 444-4011 for reimbursement.

Edited by LuvAPuppy

Angie, Pewter, and Storm-puppy

Forever missing Misty-Mousie (9/9/99 - 10/5/15)
Fort Wayne, Indiana

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Guest Mom2Shiloh

I just saw this on another list and came to check whether it had been posted here --- since I know quite a few people who have seizure dogs -- Greys and others --- it seems pretty alarming -- I hope vets and families are taking note.

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