Class II · Moderate risk Ongoing
Divalproex Sodium Delayed-Release Tablets
Reason Presence of Foreign Tablets/Capsules
Divalproex Sodium Delayed Release Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications
What was recalled
Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054, NDC 68382-031-01
- Recalling firm
- Zydus Pharmaceuticals USA Inc
- NDC code
- 68382-031-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1041-2017
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Divalproex recalls
See all
Class II · Moderate risk Terminated
Divalproex Sodium Extended-release Tablets
Reason Failed dissolution specifications
Class II · Moderate risk Terminated
Divalproex Sodium Extended Release Tablets
Reason Failed dissolution specifications.
Class II · Moderate risk Terminated
Divalproex Sodium Delayed-Release Tablets
Reason Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Class II · Moderate risk Terminated
Divalproex Sodium Extended-Release Tablets
Reason cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
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