Why it was recalled
CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
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
Lot numbers, UPCs & expiration codes
Lot #: AB06381; Exp 10/2021
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0002-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 23, 2020
- FDA report date
- Oct 7, 2020
- Quantity
- 747 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0002-2021, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 86464
- Address
- 2 Independence Way
- Code information
- Lot #: AB06381; Exp 10/2021
- Postal code
- 08540-6620
- Report date
- Oct 7, 2020
- Product type
- Drugs
- Recall number
- D-0002-2021
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 747 bottles
- Termination date
- Nov 3, 2021
- Reason for recall
- CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 23, 2020
- Initial firm notification
- Press Release
- Center classification date
- Oct 1, 2020