Why it was recalled
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Product description
Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited, Bachupally 500 090 India
Lot numbers, UPCs & expiration codes
100 count bottle - Lot #C307859, exp 09/2015; 500 count bottle - Lot #C307859 and Lot# C307812, exp 09/2015
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-1135-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 22, 2015
- FDA report date
- Jun 24, 2015
- Quantity
- 100 count 7479; 500 count - 2544
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-1135-2015, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 71374
- Address
- 107 College Rd E
- Code information
- 100 count bottle - Lot #C307859, exp 09/2015; 500 count bottle - Lot #C307859 and Lot# C307812, exp 09/2015
- Postal code
- 08540-6623
- Report date
- Jun 24, 2015
- Product type
- Drugs
- Recall number
- D-1135-2015
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 100 count 7479; 500 count - 2544
- Termination date
- Apr 24, 2017
- Reason for recall
- Failed Dissolution Specifications; exceeded specification at the 9 hour time point
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited, Bachupally 500 090 India
- Distribution pattern
- Nationwide
- Recall initiation date
- May 22, 2015
- Initial firm notification
- Letter
- Center classification date
- Jun 12, 2015