Why it was recalled
Failed Moisture Limits: Out of specification for water content
Product description
Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda HIghway, Halol-389 350 Gujarat, India, NDC 62756-142-02.
Lot numbers, UPCs & expiration codes
Lot #JKU4639A, Exp 10/2022
Where it was sold
Nationwide in the USA
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-0325-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 25, 2021
- FDA report date
- Apr 14, 2021
- Quantity
- 2520 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0325-2021, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 87617
- Address
- 2 Independence Way
- Code information
- Lot #JKU4639A, Exp 10/2022
- Postal code
- 08540-6620
- Report date
- Apr 14, 2021
- Product type
- Drugs
- Recall number
- D-0325-2021
- Classification
- Class III
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 2520 bottles
- Termination date
- Apr 14, 2022
- Reason for recall
- Failed Moisture Limits: Out of specification for water content
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda HIghway, Halol-389 350 Gujarat, India, NDC 62756-142-02.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 25, 2021
- Initial firm notification
- Letter
- Center classification date
- Apr 7, 2021