News Releases

December 7, 2012

Qualitest Recalls Hydrocodone Bitartrate and Acetaminophen Tablets, Usp 10 Mg/500 Mg Due to the Potential for Oversized Tablets

The Missouri Department of Health and Senior Services received information regarding the recall of 101 lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg. This includes product with the following NDC numbers and lot numbers beginning with the letter "C".

NDC Number

Bottle Count

0603-3888-16

30

0603-3888-20

60

0603-3888-02

90

0603-3888-21

100

0603-3888-22

120

0603-3888-26

150

0603-3888-04

180

0603-3888-28

500

0603-3888-32

1000

Bottles from the affected lots may contain tablets that have a higher dosage of acetaminophen, and as a result, it is possible that consumers could take more than the intended acetaminophen dose. Unintentional administration of tablets with increased acetaminophen content could result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day.

The affected lots were distributed between Feb. 20, 2012 and Nov. 19, 2012 to wholesale distributors and retail pharmacies nationwide. The lot number can be found on the side of the manufacturer's bottle.

The full recall can be found at www.fda.gov/Safety/Recalls/ucm331218.htm.

###