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
Reported: April 24, 2019 Initiated: April 11, 2019 #D-1133-2019
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
Reason for Recall
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- 33,958 bottles
- Distribution
- Product was distributed to major distributors and retailers who may have further distribute the product throughout the United States.
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 33,958 bottles.
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 April 24, 2019. Severity: Moderate. Recall number: D-1133-2019.
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