PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: April 21, 2021 Initiated: March 31, 2021 #D-0334-2021

Product Description

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

Details

Units Affected
13,834 bottles
Distribution
Nationwide within the United States
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC. Units affected: 13,834 bottles.
Why was this product recalled?
Microbial Contamination of Non-Sterile Product
Which agency issued this recall?
This recall was issued by the FDA Drug on April 21, 2021. Severity: Moderate. Recall number: D-0334-2021.