Mylan Inc. said Thursday that it is voluntarily recalling three lots of a painkiller tablet because of the risk that it may exceed the appropriate potency.
The hydrocodone bitartrate and acetaminophen pills were manufactured by Qualitest Pharmaceuticals, and Mylan Institutional repackaged and distributed the product under the UDL Laboratories Inc. label.
Qualitest Pharmaceuticals first initiated the recall on Dec. 6 due to the possibility that a small number of tablets from the affected lots may exceed the weight requirement and could exceed the label claim potency requirements for the ingredients hydrocodone bitartrate and acetaminophen. Use of tablets with increased acetaminophen could cause liver damage in some people.
Consumers can contact Mylan Customer Service with questions at 1-800-848-0462 on Monday through Friday between 8 a.m. and 5 p.m. EST. Additional information can be found at: http://www.fda.gov/Safety/Recalls/ucm331218.htm.