Why it was recalled
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Product description
Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC 55111-0533-05), Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, - 500 090 INDIA
Lot numbers, UPCs & expiration codes
Lot #: a) C802629, Exp. 03/2020; C805680, Exp. 07/2020, C808821,Exp. 10/2020; b) C806561, Exp. 10/2020
Where it was sold
Product was distributed to major distributors and retailers who may have further distribute the product throughout 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-1133-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 11, 2019
- FDA report date
- Apr 24, 2019
- Quantity
- 33,958 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-1133-2019, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 82617
- Address
- 107 College Rd E
- Code information
- Lot #: a) C802629, Exp. 03/2020; C805680, Exp. 07/2020, C808821,Exp. 10/2020; b) C806561, Exp. 10/2020
- Postal code
- 08540-6623
- Report date
- Apr 24, 2019
- Product type
- Drugs
- Recall number
- D-1133-2019
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 33,958 bottles
- Termination date
- Jun 25, 2020
- Reason for recall
- cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC 55111-0533-05), Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, - 500 090 INDIA
- Distribution pattern
- Product was distributed to major distributors and retailers who may have further distribute the product throughout the United States.
- Recall initiation date
- Apr 11, 2019
- Initial firm notification
- Letter
- Center classification date
- Apr 15, 2019