Why it was recalled
Failed Dissolution Specifications: Out of specification results observed for high dissolution.
Product description
Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India NDC 55111-533-01
Lot numbers, UPCs & expiration codes
Lot #: C802676, Exp 03/20
Where it was sold
U.S.A. 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-0507-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 31, 2019
- FDA report date
- Feb 27, 2019
- Quantity
- 10,656 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0507-2019, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 82085
- Address
- 107 College Rd E
- Code information
- Lot #: C802676, Exp 03/20
- Postal code
- 08540-6623
- Report date
- Feb 27, 2019
- Product type
- Drugs
- Recall number
- D-0507-2019
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 10,656 bottles
- Termination date
- Feb 14, 2023
- Reason for recall
- Failed Dissolution Specifications: Out of specification results observed for high dissolution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India NDC 55111-533-01
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Jan 31, 2019
- Initial firm notification
- Letter
- Center classification date
- Feb 15, 2019