FDA-Drug2014-07-30Class I

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

Shamrock Medical Solutions Group LLC
Hazard

Labeling: Label Mix up; product labeled did not indicated Extended Release

Sold states
Product was shipped to the following states: CO, MA, OH, TX & WY.
Affected count
88/5 mg tablets
Manufactured in
741 Radio Dr, Lewis Center, OH, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1448-2014

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