FDA recall D-0325-2021

Product

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.

Reason for recall

Failed Moisture Limits: Out of specification for water content

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2021-03-25

Report date

2021-04-14

Termination date

2022-04-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0325-2021