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
D-0002-2021
Product summary
- Event
- Event 86464
- Status
- Terminated
- Classification
- Class II
- Quantity
- 747 bottles
- Official record key
drug-enforcement:D-0002-2021
Official wording
Reason: CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
Code information: Lot #: AB06381; Exp 10/2021
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
NDMA) impurity
-
Manufacturing or process control
CGMP Deviations