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

Recall Number: D-0002-2021

Firm: SUN PHARMACEUTICAL INDUSTRIES INC

Classification: Class II

Status: Terminated

Report Date: 20201007

Initiation Date: 20200923

Termination Date: 20211103

CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug 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