Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited Bachupally 500 090 India --- NDC 55111-534-01
Reported: June 24, 2015 Initiated: May 22, 2015 #D-1136-2015
Product Description
Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited Bachupally 500 090 India --- NDC 55111-534-01
Reason for Recall
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- 5,160 bottles
- Distribution
- Nationwide
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited Bachupally 500 090 India --- NDC 55111-534-01. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 5,160 bottles.
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-1136-2015.
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