Recalls / Class I
Class ID-1448-2014
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Affected lot / code info
- Lot #: 00267J Use By: 7/28/2012 NDC: 53746-178-01
Why it was recalled
Labeling: Label Mix up; product labeled did not indicated Extended Release
Recalling firm
- Firm
- Shamrock Medical Solutions Group LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 741 Radio Dr, Lewis Center, Ohio 43035-7134
Distribution
- Quantity
- 88/5 mg tablets
- Distribution pattern
- Product was shipped to the following states: CO, MA, OH, TX & WY.
Timeline
- Recall initiated
- 2011-09-27
- FDA classified
- 2014-07-23
- Posted by FDA
- 2014-07-30
- Terminated
- 2014-07-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1448-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.