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 Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152. NDC # 0904-6363-61.
Lot numbers, UPCs & expiration codes
Lot# M02250 EXP 10/2020.
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-1583-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 24, 2019
- FDA report date
- Aug 7, 2019
- Quantity
- 828 100-count unit dose cartons
- Recall type
- N/A
- Recalling firm
- MAJOR PHARMACEUTICALS
Original FDA data
Every field from FDA enforcement report D-1583-2019, exactly as published.
Show all FDA fields
- City
- Livonia
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 83460
- Address
- 17177 N Laurel Park Dr
- Code information
- Lot# M02250 EXP 10/2020.
- Postal code
- 48152-2693
- Report date
- Aug 7, 2019
- Product type
- Drugs
- Recall number
- D-1583-2019
- Classification
- Class II
- Recalling firm
- MAJOR PHARMACEUTICALS
- Product quantity
- 828 100-count unit dose cartons
- Termination date
- Jul 16, 2020
- Reason for recall
- cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
- Product description
- DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152. NDC # 0904-6363-61.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 24, 2019
- Center classification date
- Aug 1, 2019