Drug product
Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottle, Manufactured by: Mikart, Inc., Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 10631-206-02
D-0818-2018
Product summary
- Event
- Event 79979
- Status
- Terminated
- Classification
- Class III
- Quantity
- 19,758 473 mL bottles
- Official record key
drug-enforcement:D-0818-2018
Official wording
Reason: Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.
Code information: Lot Numbers: E170210A, EXP 06/09/2019; F170214A, 07/05/2019; F170223A, EXP 07/06/2019; F170224A EXP 07/10/2019; F170231A , EXP 07/12/2019; F170232A EXP 07/13/2019.
Distribution pattern: US Nationwide in the USA
Derived failure modes
-
Unknown
Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.