Why it was recalled
Microbial Contamination of Non-Sterile Product
Product description
Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 fl. oz., 473 mL bottles Rx Only, Manufactured by: Mikart, LLC, Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 10631-206-02.
Lot numbers, UPCs & expiration codes
Lot #: J190386A, X190354A, Exp. 3/2021, J190393A, Exp. 5/2021, A200035A, Exp. 6/2021, B200064A, Exp. 8/2021; H200236A, Exp. 1/2022
Where it was sold
Nationwide within the United States
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-0334-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 31, 2021
- FDA report date
- Apr 21, 2021
- Quantity
- 13,834 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0334-2021, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 87650
- Address
- 2 Independence Way
- Code information
- Lot #: J190386A, X190354A, Exp. 3/2021, J190393A, Exp. 5/2021, A200035A, Exp. 6/2021, B200064A, Exp. 8/2021; H200236A, Exp. 1/2022
- Postal code
- 08540-6620
- Report date
- Apr 21, 2021
- Product type
- Drugs
- Recall number
- D-0334-2021
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 13,834 bottles
- Termination date
- Apr 14, 2022
- Reason for recall
- Microbial Contamination of Non-Sterile Product
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 fl. oz., 473 mL bottles Rx Only, Manufactured by: Mikart, LLC, Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 10631-206-02.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Mar 31, 2021
- Initial firm notification
- Letter
- Center classification date
- Apr 13, 2021