metFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate Release (IR), Repac...
FDA Recall #D-1448-2014 — Class I — September 27, 2011
Product Description
metFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate Release (IR), Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Amneal/Interpharm, Hauppauge, NY NDC 53746-178-01
Reason for Recall
Labeling: Label Mix up; product labeled did not indicated Extended Release
Recalling Firm
Shamrock Medical Solutions Group LLC — Lewis Center, OH
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
88/5 mg tablets
Distribution
Product was shipped to the following states: CO, MA, OH, TX & WY.
Code Information
Lot #: 00267J Use By: 7/28/2012 NDC: 53746-178-01
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated