FDA Recall Terminated Historical recordClass II
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
- Reason
- CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
- Published
- October 7, 2020
- Distribution
- Nationwide
