D-1448-2014 Class I Terminated
FDA drug recall D-1448-2014 was initiated by Shamrock Medical Solutions Group LLC on Sep 27, 2011 and is designated Class I. Reason for recall: Labeling: Label Mix up; product labeled did not indicated Extended Release The recall status is terminated (terminated Jul 31, 2014). Affected quantity: 88/5 mg tablets.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 30, 2014
- Initiation Date
- Sep 27, 2011
- Termination Date
- Jul 31, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 88/5 mg tablets
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
Distribution Pattern
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