Recalls / Class II
Class IID-1583-2019
Product
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.
- Brand name
- Divalproex Sodium
- Generic name
- Divalproex Sodium
- Active ingredient
- Divalproex Sodium
- Route
- Oral
- NDC
- 0904-6363
- FDA application
- ANDA090161
- Affected lot / code info
- Lot# M02250 EXP 10/2020.
Why it was recalled
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Recalling firm
- Firm
- MAJOR PHARMACEUTICALS
- Manufacturer
- Major Pharmaceuticals
- Notification channel
- N/A
- Type
- N/A
- Address
- 17177 N Laurel Park Dr, N/A, Livonia, Michigan 48152-2693
Distribution
- Quantity
- 828 100-count unit dose cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-04-24
- FDA classified
- 2019-08-01
- Posted by FDA
- 2019-08-07
- Terminated
- 2020-07-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1583-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.