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
Reported: July 30, 2014 Initiated: September 27, 2011 #D-1448-2014
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
Details
- Recalling Firm
- Shamrock Medical Solutions Group LLC
- Units Affected
- 88/5 mg tablets
- Distribution
- Product was shipped to the following states: CO, MA, OH, TX & WY.
- Location
- Lewis Center, OH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Shamrock Medical Solutions Group LLC. Units affected: 88/5 mg tablets.
Why was this product recalled? ▼
Labeling: Label Mix up; product labeled did not indicated Extended Release
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 30, 2014. Severity: Critical. Recall number: D-1448-2014.
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