FDA-Drug2021-04-14Class III

Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, 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

Failed Moisture Limits: Out of specification for water content

Sold states
Nationwide in the USA
Affected count
2520 bottles
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, 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-0325-2021

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