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.
Reported: August 7, 2019 Initiated: April 24, 2019 #D-1583-2019
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.
Reason for Recall
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Details
- Recalling Firm
- MAJOR PHARMACEUTICALS
- Units Affected
- 828 100-count unit dose cartons
- Distribution
- Nationwide in the USA
- Location
- Livonia, MI
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by MAJOR PHARMACEUTICALS. Units affected: 828 100-count unit dose cartons.
Why was this product recalled? ▼
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 7, 2019. Severity: Moderate. Recall number: D-1583-2019.
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