NEWS - FDA: Voluntary recall of hydrocodone bitartrate and acetaminophen and phenobarbital tablets

[Guest guest]

FDA

Safety - Recalls

05 Feb 2011

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 naïve 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.

********************************************************

Read the full article here:

http://www.fda.gov/Safety/Recalls/ucm242398.htm

Not an MD