12/20/2012 08:06 am ET Updated Feb 19, 2013

Generic Vicodin Recalled Because Tablets Made Too Large

Dec 20 (Reuters) - Generic drug maker Mylan Inc said on Thursday it is recalling three lots of hydrocone bitartrate, the generic name for Vicodin, and acetaminophen tablets because of concerns that a small number of tablets were too large and therefore too strong.

The drugs were made for Mylan by Qualitest, a unit of Endo Health Solutions Inc, which recalled 101 lots of the pills earlier this month on concerns over the oversized drugs.

The increased acetaminophen content could cause damage to the liver, particularly if the patient is already taking acetaminophen, has liver dysfunction, or consumes more than 3 alcoholic beverages a day, the Food and Drug Administration said on Dec. 6 when Qualitest started the recall.

The recall affects only pills labeled as having 10 milligrams of hydrocodone bitartrate and 500 milligrams of acetaminophen, the generic ingredient in Tylenol.