The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose.
405 FDA drug recalls with this cause, newest first.
These recalls happen when a tablet or capsule does not dissolve the way its specification requires. Because dissolution controls how the drug is released, a failure can mean a patient absorbs it too slowly, too quickly, or not at all - a particular concern for extended-release products, where the release profile is the whole point.
Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.
Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.
Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point
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