Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited, Bachupally 500 090 India
Reported: June 24, 2015 Initiated: May 22, 2015 #D-1135-2015
Product Description
Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited, Bachupally 500 090 India
Reason for Recall
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- 100 count 7479; 500 count - 2544
- Distribution
- Nationwide
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited, Bachupally 500 090 India. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 100 count 7479; 500 count - 2544.
Why was this product recalled? ▼
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 24, 2015. Severity: Moderate. Recall number: D-1135-2015.
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