Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ
Reported: April 5, 2017 Initiated: March 15, 2017 #D-0617-2017
Product Description
Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ
Reason for Recall
Failed Dissolution Specifications; 9 month long term stability
Details
- Recalling Firm
- Zydus Pharmaceuticals USA Inc
- Units Affected
- 32628 bottles
- Distribution
- Nationwide
- Location
- Pennington, NJ
Frequently Asked Questions
What product was recalled? ▼
Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ. Recalled by Zydus Pharmaceuticals USA Inc. Units affected: 32628 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications; 9 month long term stability
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 5, 2017. Severity: Moderate. Recall number: D-0617-2017.
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