FDA recall D-0109-2018

Product

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

Reason for recall

Microbial Contamination of Non-Sterile Products

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-04-18

Report date

2017-12-20

Termination date

2018-05-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cranbury, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0109-2018