D-0002-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 7, 2020
- Initiation Date
- September 23, 2020
- Termination Date
- November 3, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 747 bottles
Product Description
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.
Distribution Pattern
Nationwide
Code Information
Lot #: AB06381; Exp 10/2021