FDA-Drug2021-04-21Class II
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.
Hazard
Microbial Contamination of Non-Sterile Product
Sold states
Nationwide within the United States
Affected count
13,834 bottles
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0334-2021More SUN PHARMACEUTICAL INDUSTRIES INC recalls
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