Qualitest issues voluntary, nationwide recall for lot of hydrocodone bitartrate and acetaminophen tablets

Qualitest, a subsidiary of Endo Health Solutions, today issued a voluntary, nationwide retail-level recall for 1 lot of hydrocodone bitartrate and acetaminophen tablets, USP 10 mg/500 mg. Hydrocodone bitartrate and acetaminophen 10 mg/500 mg tablets are indicated for the relief of moderate to moderately severe pain.

The recall includes the following product lot:Hydrocodone bitartrate and acetaminophen tablets, USP 10 mg/500 mg, NDC 0603-3888-21, 100 count, Lot Number C1440512A, expiration date 12/13.

It is possible that some tablets from lot C1440512A exceed the weight specification and could be super-potent for the ingredients hydrocodone bitartrate and acetaminophen.Bottles from the affected lot 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. Taking a higher dose of hydrocodone than intended could result in an increase in the severity or frequency of side effects, such as sedation or respiratory depression, particularly in patients who are elderly, have severe kidney or liver impairment, or are also taking interacting medications (for example, other sedating medications or certain antidepressants).

To date, no injuries have been reported.

The affected lot, C1440512A, was distributed between May 14 and August 3, 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, pink, capsule-shaped tablets, with "3600" debossed on one side of the tablet and "V" on the other.

Consumers who have lot C1440512A should contact Qualitest at(800) 444-4011. Consumers who are unsure if they have the affected lot number should consult their pharmacy or healthcare professional.

Pharmacists and wholesalers are asked to check their inventories for lot C1440512A, segregate any material from the lot, and to contact MedTurn at (800) 967-5952 for instructions on product return. Pharmacies that received lot C1440512A will receive a copy of this press release with their recall notification information. To make patients aware of this recall, pharmacists should post the press release prominently in the pharmacy area.

For more information, or to report adverse reactions or quality problems, contact Qualitest at (800) 444-4011; Monday through Friday between the hours of 8 a.m. and 5 p.m. CST.

Adverse reactions or quality problems experienced with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either on line, by regular mail, or by fax.

• Complete and submit the report online: www.fda.gov/MedWatch/report.htm

• Download form or call (800) 332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to (800) FDA-0178