Drug 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.
D-0334-2021
Product summary
- Event
- Event 87650
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,834 bottles
- Official record key
drug-enforcement:D-0334-2021
Official wording
Reason: Microbial Contamination of Non-Sterile Product
Code information: Lot #: J190386A, X190354A, Exp. 3/2021, J190393A, Exp. 5/2021, A200035A, Exp. 6/2021, B200064A, Exp. 8/2021; H200236A, Exp. 1/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Microbial contamination
Microbial Contamination