DIVALPROEX SODIUM
Generic: DIVALPROEX SODIUM
DIVALPROEX SODIUM is FDA application ANDA217358, sponsored by MANKIND PHARMA. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Recalls
Failed Dissolution Specifications: Out of specification results observed for high dissolution.
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution
Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex
Presence of Foreign Tablets/Capsules
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Failed dissolution specifications.
Failed dissolution specifications
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.