FDA recall D-0334-2021

Product

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

Reason for recall

Microbial Contamination of Non-Sterile Product

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2021-03-31

Report date

2021-04-21

Termination date

2022-04-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0334-2021