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Qualitest Issues Voluntary, Nationwide Recall of 101 Lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg Due to the Potential for Oversized Tablets
Date:12/6/2012

HUNTSVILLE, Ala., Dec. 6, 2012 /PRNewswire/ -- Qualitest, a subsidiary of Endo Health Solutions, (Nasdaq: ENDP) today issued a voluntary nationwide recall for 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 Count0603-3888-16

300603-3888-20

600603-3888-02

900603-3888-21

1000603-3888-22

1200603-3888-26

1500603-3888-04

1800603-3888-28

5000603-3888-32

1000It is possible that a number of tablets from the affected lots may exceed the weight requirement and could exceed the label claim potency requirements for the ingredients of  hydrocodone bitartrate and acetaminophen. Hydrocodone bitartrate and acetaminophen 10mg/500 mg tablets are indicated for the relief of moderate to moderately severe pain. 

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 product label warns consumers that acetaminophen overdose can potentially cause severe liver damage, at times resulting in liver transplant or death.

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.  Hydrocodone Bitartrate and Acetaminophen Tablets are approximately 16.51 mm in length,
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SOURCE Qualitest
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