Drug product
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
D-1448-2014
Product summary
- Event
- Event 64611
- Status
- Terminated
- Classification
- Class I
- Quantity
- 88/5 mg tablets
- Official record key
drug-enforcement:D-1448-2014
Official wording
Reason: Labeling: Label Mix up; product labeled did not indicated Extended Release
Code information: Lot #: 00267J Use By: 7/28/2012 NDC: 53746-178-01
Distribution pattern: Product was shipped to the following states: CO, MA, OH, TX & WY.
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix up