RECALL: FDA Advises Vets About Recall of Human Drug Phenobarbital
FDA Advises Veterinarians of Recent Recall of Human Drug, Phenobarbitol
Drug is Prescribed for Animals Extralabel
March 10, 2011
The Food and Drug Administrationís 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.
The Recall Notice For Humans With The Lot #s Follows
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
FOR IMMEDIATE RELEASE - February 5, 2011 - Qualitest Pharmaceuticals today issued a voluntary nationwide recall of 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. An individual bottle of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count was found incorrectly labeled with a Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count label, printed with Lot Number T150G10B. Lots T120J10E and T023M10A used the same stock inventory of labels as Lot T150G10B and are potentially impacted.
As a result of this mix-up patients may unintentionally take Hydrocodone and acetaminophen tablets, instead of the intended dose of Phenobarbital. Unintentional administration of Hydrocodone can lead to serious adverse events including respiratory depression, CNS depression, coma and death, especially in opioid naÔve patients and patients on other CNS depressants. Unintentional administration of acetaminophen may result in liver toxicity in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day. Additionally, missing doses of Phenobarbital could result in loss of seizure control.
No injuries have been reported to date.
Consumers who have affected product should stop using the product and contact Qualitest at 1-800-444-4011 for reimbursement. The lot number can be found on the side of the bottle.
The recall includes the following products:
* Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count, Lot Numbers T150G10B, T120J10E and T023M10A
* Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count, Lot Numbers T150G10B, T120J10E and T023M10A
This voluntary recall is being made with the knowledge of the U.S. Food and Drug Administration.
These lots were distributed between Sept. 21, 2010 and Dec. 29, 2010 to wholesale and retail pharmacies nationwide (including Puerto Rico). Lot numbers can be found on the side of the bottle. Hydrocodone Bitartrate and Acetaminophen Tablets are large (approximately 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 (approximately 6.4 mm in diameter), white, round, biconvex, scored tablets, debossed (5012) and (V) on one side and plain on the reverse side. All patients who have filled prescriptions of Phenobarbitol manufactured by Qualitest, are asked to double check the identity of their tablets.
Qualitest is notifying all customers who may have received affected product and arranging for the return of any affected product.
Consumers with questions may contact Qualitest at 1-800-444-4011 for more information.
Adverse reactions or quality problems experienced with the use of this product may be reported to the manufacturer or to FDAís MedWatch Adverse Event Reporting program either on line, by regular mail, or by fax.
* Telephone: 1-800-444-4011
* Online: http://www.fda.gov/MedWatch/report.htm1
* Regular Mail: Use postage-paid FDA form 3500 available at: http://www.fda.gov/MedWatch/getforms.htm2 Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
* Fax: 1-800-FDA-0178
Founded in 1983, Qualitest provides affordable, high-quality generic pharmaceuticals. Featuring a current portfolio exceeding 600 products, the company has grown significantly since its inception and is now ranked in the top ten among all suppliers of generics, based on total prescriptions filled. Qualitest is a wholly owned subsidiary of Endo Pharmaceuticals (Nasdaq: ENDP), a U.S.-based, specialty healthcare solutions company, focused on high-value branded products and specialty generics (www.endo.com3).
If your pet is on Phenobarbital for Seizures or anything else, Please contact your Veterinarian or Pharmacy
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