Riomet (metformin hydrochloride oral solution)…

Date

May 23, 2018

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

Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottle, Manufactured by: Mikart, Inc., Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 10631-206-02

Reason

Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.

Distribution pattern

US Nationwide in the USA

Quantity

19,758 473 mL bottles

Codes and lots

Lot Numbers: E170210A, EXP 06/09/2019; F170214A, 07/05/2019; F170223A, EXP 07/06/2019; F170224A EXP 07/10/2019; F170231A , EXP 07/12/2019; F170232A EXP 07/13/2019.

Recall started

April 26, 2018

Recall number

D-0818-2018

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-0818-2018. The agency record governs; check it and the company before acting.