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
Reason for recall: CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
Recall initiated: 20200923
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated