D-0334-2021 Class II Terminated
FDA drug recall D-0334-2021 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on March 31, 2021 and is designated Class II. Reason for recall: Microbial Contamination of Non-Sterile Product The recall status is terminated (terminated April 14, 2022). Affected quantity: 13,834 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 21, 2021
- Initiation Date
- March 31, 2021
- Termination Date
- April 14, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,834 bottles
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
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: J190386A, X190354A, Exp. 3/2021, J190393A, Exp. 5/2021, A200035A, Exp. 6/2021, B200064A, Exp. 8/2021; H200236A, Exp. 1/2022