Riomet Oral Solution Cherry Flavored 500 mg / recalled over sterility concerns

Recall date

April 18, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Sun Pharmaceutical Industries, Inc. recalls Riomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg /5 mL, 4 fl. oz. (NDC 10631-206-01) and 16 fl. oz…

Recall number

D-0109-2018

FDA classification

Class II

Brand / firm

Sun Pharmaceutical Industries, Inc.

Sold / distributed

Nationwide

Why it was recalled

Microbial Contamination of Non-Sterile Products

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Riomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg /5 mL, 4 fl. oz. (NDC 10631-206-01) and 16 fl. oz. (NDC 10631-206-02) HDPE bottles, Rx only, Manufactured for: Ranbaxy Laboratories Inc. Jacksonville, FL 32257 USA, Distributed by: Sun Pharmaceutical Industries, Cranbury, NJ 08512