Saturday, March 12, 2011

PHENOBARBITAL 32.4 MG RECALL - MISLABELED - PLEASE READ

We wanted to forward some information regarding an urgent recall related
to 32.4 mg Phenobarbital labeled product: Please see below for details and
please share on your listserves.

Forwarded message from the NCSU-CVM Pharmacist, Gigi Davidson:

Please read below. Apparently Qualitest has mislabeled hydrocodone
10mg/acetaminophen 500mg tablets as phenobarbital 32.4mg tablets.
Several adverse drug reactions have already been reported in dogs
receiving the mislabeled drug (probably acetaminophen toxicity).

The VTH pharmacy has not ever stocked Qualitest Phenobarbital 32mg
tablets, but please inform any clients that have had prescriptions
filled at other pharmacies for phenobarbital 30mg to contact their
pharmacies to be certain that this mislabeled product was not dispensed.

Unfortunately, no affected lot numbers have been reported yet.

Please click here for the fda link

http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm246624.htm


*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 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

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