Recalls / Class II
Class IID-0002-2021
Product
RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL 16 oz. For Oral Use Only Rx Only Manufactured by: Sun Pharmaceuticals Industries Limited Mohali, India Distributed by: Sun Pharmaceuticals Industries, Inc. Cranbury, NJ 08512 NDC 10631-019-17
- Affected lot / code info
- Lot #: AB06381; Exp 10/2021
Why it was recalled
CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 747 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2020-09-23
- FDA classified
- 2020-10-01
- Posted by FDA
- 2020-10-07
- Terminated
- 2021-11-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0002-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.