Why it was recalled
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Product description
Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol- 389 350, Gujarat, India, NDC 62756-798-88.
Lot numbers, UPCs & expiration codes
Lot: HAC1312A, EXP. 05/2024
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-1291-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 27, 2022
- FDA report date
- Aug 3, 2022
- Quantity
- 9552 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-1291-2022, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90495
- Address
- 2 Independence Way
- Code information
- Lot: HAC1312A, EXP. 05/2024
- Postal code
- 08540-6620
- Report date
- Aug 3, 2022
- Product type
- Drugs
- Recall number
- D-1291-2022
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 9552 bottles
- Termination date
- May 31, 2023
- Reason for recall
- Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol- 389 350, Gujarat, India, NDC 62756-798-88.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 27, 2022
- Initial firm notification
- Letter
- Center classification date
- Jul 26, 2022