Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle (NDC 68382-033-05), Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054
Reported: August 9, 2017 Initiated: May 10, 2017 #D-1043-2017
Product Description
Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle (NDC 68382-033-05), Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054
Reason for Recall
Failed Dissolution Specifications
Details
- Recalling Firm
- Zydus Pharmaceuticals USA Inc
- Units Affected
- 108,726 HDPE bottles
- Distribution
- Nationwide
- Location
- Pennington, NJ
Frequently Asked Questions
What product was recalled? ▼
Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle (NDC 68382-033-05), Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054. Recalled by Zydus Pharmaceuticals USA Inc. Units affected: 108,726 HDPE bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 9, 2017. Severity: Moderate. Recall number: D-1043-2017.
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