Metformin HCl Extended-Release Tablets…

Date

April 14, 2021

Risk class

Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)

Status

Terminated

Filed by

Sun Pharmaceutical Industries Inc

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

Failed Moisture Limits: Out of specification for water content

Distribution pattern

Nationwide in the USA

Quantity

2520 bottles

Codes and lots

Lot #JKU4639A, Exp 10/2022

Recall started

March 25, 2021

Recall number

D-0325-2021

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-0325-2021. The agency record governs; check it and the company before acting.