FDA-Drug2014-03-05Class II

Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: Sun Pharmaceutical Inc. Ltd, Andheri (East) Mumbai-400 059, India, Distributed by: Caraco Pharmaceutical Laboratories, Ltd, Detroit, MI --- NDC 62756-142-02

Caraco Pharmaceutical Laboratories, Ltd.
Hazard

Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER

Sold states
Nationwide
Affected count
2528 bottles
Manufactured in
1150 Elijah McCoy Dr, Detroit, MI, United States
Products
Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: Sun Pharmaceutical Inc. Ltd, Andheri (East) Mumbai-400 059, India, Distributed by: Caraco Pharmaceutical Laboratories, Ltd, Detroit, MI --- NDC 62756-142-02

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1089-2014

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