Sun Pharmaceuticals Recalls RIOMET ER Due to NDMA Impurity
Sun Pharmaceuticals is recalling RIOMET ER (metformin hydrochloride) oral suspension because it contains the impurity NDMA.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the presence of NDMA, a potential carcinogen, in a drug product constitutes a significant health risk warranting a Severe rating.
Plain-English summary
Sun Pharmaceuticals Industries, Inc. is recalling RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL, 16 oz bottles. The recall involves 747 bottles with Lot # AB06381 and an expiration date of 10/2021. The product was distributed nationwide.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the impurity N-nitrosodimethylamine (NDMA) in the finished drug product. NDMA is a potential carcinogen that is regulated in pharmaceutical products.
Consumers who have this specific lot of RIOMET ER should stop using the product and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The product should be returned to the pharmacy or disposed of according to local regulations.
The recalled product
- 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 10631-019-1
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 747
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: AB06381
- Exp 10/2021
Distribution
Distributed nationwide across the United States.
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