Recalls / Class III
Class IIID-0818-2018
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
- 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 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.
Why it was recalled
Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.
Recalling firm
- Firm
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 270 Prospect Plains Rd, Cranbury, New Jersey 08512-3605
Distribution
- Quantity
- 19,758 473 mL bottles
- Distribution pattern
- US Nationwide in the USA
Timeline
- Recall initiated
- 2018-04-26
- FDA classified
- 2018-05-16
- Posted by FDA
- 2018-05-23
- Terminated
- 2019-02-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0818-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.