FDA Recall D-1448-2014
Shamrock Medical Solutions Group LLC · Lewis Center, OH
Class I — life-threatening Terminated 1038 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Reason for recall
Labeling: Label Mix up; product labeled did not indicated Extended Release
Recall record
- Recall number
D-1448-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- Distribution
- Product was shipped to the following states: CO, MA, OH, TX & WY.
- Recall initiated
- 2011-09-27
- Classified by FDA Center
- 2014-07-23
- FDA published
- 2014-07-30
- Terminated
- 2014-07-31
- Recalling firm
- Shamrock Medical Solutions Group LLC
- Firm location
- Lewis Center, OH