FDA recall D-0372-2021

Product

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.

Reason for recall

Presence of foreign substance: identified as activated carbon.

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2021-05-04

Report date

2021-05-19

Termination date

2023-06-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

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