A voluntary product recall is being initiated by Qualitest Pharmaceuticals of Hydrocodone Bitartrate and Acetaminophen tablets that have been distributed by Mylan Institutional under the UDL Laboratories, Inc. label. During compounding some tablets became heavier than others and thus may exceed more than the label’s claim of strength of acetaminophen, which could become toxic in some patients who may already have liver dysfunction.
10 mg/500 mg Tablets in Lots 3037841, 3040859 and 3042573 are affected by this recall. The tablets were manufactured by Qualitest Pharmaceuticals, and were repackaged and sold by Mylan Institutional under the UDL Laboratories, Inc. label.
More information about this recall can be obtained by visiting the U.S. Food and Drug Administration (FDA) website: http://www.fda.gov/Safety/Recalls/ucm331218.htm
Consumers who have purchased the affected tablets can call Mylan Customer Service on their toll-free number 1(800)848-0462, Monday through Friday from 8 a.m. until 5 p.m. Eastern Standard Time.