Riomet ER recall: Nitrosamine Impurity
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
Why was Riomet ER recalled?
CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: AB06381; Exp 10/2021
- 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
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Quantity
- 747 bottles
- Distribution
- Nationwide
- Recall date
- October 7, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)