Recalls / Class II
Class IID-0334-2021
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.
- Brand name
- Riomet
- Generic name
- Metformin Hydrochloride
- Active ingredient
- Metformin Hydrochloride
- Route
- Oral
- NDCs
- 10631-206, 10631-238
- FDA application
- NDA021591
- Affected lot / code info
- Lot #: J190386A, X190354A, Exp. 3/2021, J190393A, Exp. 5/2021, A200035A, Exp. 6/2021, B200064A, Exp. 8/2021; H200236A, Exp. 1/2022
Why it was recalled
Microbial Contamination of Non-Sterile Product
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 13,834 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2021-03-31
- FDA classified
- 2021-04-13
- Posted by FDA
- 2021-04-21
- Terminated
- 2022-04-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0334-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.