Qualitest has voluntarily expanded a painkiller recall initiated in September from one lot to 100 lots due to concerns that the medication may contain excess acetominophen.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg may contain tablets with a higher than labeled dose of acetaminophen, putting patients at risk for overdose, the drug maker said in a press release.
Acetominophen overdose can cause liver toxicity in patients taking other acetaminophen-containing medications, those with liver dysfunction or those who consume more than three alcoholic beverages a day.
The recall includes 101 lots distributed to retail outlets and wholesale distributors from Feb. 20, 2012 to Nov. 19, 2012. Affected lots start with the letter “C” and include 30 to 1,000 count bottles. NDC numbers start with 0603-3888 and end in in 16, 20, 02, 21, 22, 26, 04, 28 and 32.
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. the lot number can be found on the side of the manufacturer’s bottle.
Pharmacists and wholesalers should remove affected lots from their inventory immediately and contact MedTurn at 1-800-967-5952 for instructions on how to return the product.