FDA-Drug2021-05-19Class II

Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-142-02.

SUN PHARMACEUTICAL INDUSTRIES INC
Hazard

Presence of foreign substance: identified as activated carbon.

Sold states
USA Nationwide
Affected count
50868 bottles
Manufactured in
2 Independence Way, Princeton, NJ, United States
Products
Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-142-02.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0372-2021

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