RIOMET ER (metformin hydrochloride for extended-release oral suspension)…

Date

Oct. 7, 2020

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

Sun Pharmaceutical Industries Inc

Product

RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL 16 oz. For Oral Use Only Rx Only Manufactured by: Sun Pharmaceuticals Industries Limited Mohali, India Distributed by: Sun Pharmaceuticals Industries, Inc. Cranbury, NJ 08512 NDC 10631-019-17

Reason

CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.

Distribution pattern

Nationwide

Quantity

747 bottles

Codes and lots

Lot #: AB06381; Exp 10/2021

Recall started

Sept. 23, 2020

Recall number

D-0002-2021

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-0002-2021. The agency record governs; check it and the company before acting.