PlainRecalls
FDA Drug Critical Class I Terminated

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

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.