Class III · Low risk
Cardizem CD
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Dissolution failure
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.
Class III · Low risk
Cardizem CD
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Class III · Low risk
Cardizem CD
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Class III · Low risk
Temozolomide Capsules
Failed Dissolution Specifications
Class III · Low risk
Temozolomide Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Olmesartan Medoxomil and Hydrochlorothiazide Tablets
Failed dissolution specifications
Class II · Moderate risk
Nevirapine Extended Release Tablets
Failed Dissolution Specifications.
Class II · Moderate risk
Clopidogrel Tablets
Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability testing.
Class II · Moderate risk
Clopidogrel Tablets
Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.
Class II · Moderate risk
Catapres .2
Failed Dissolution Specifications: OOS resultsduring routine stability testing
Class II · Moderate risk
Metoprolol Succinate Extended Release Tablets
Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.
Class III · Low risk
Temozolomide capsules
Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
Class II · Moderate risk
Lamotrigine Extended-Release Tablets
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Class II · Moderate risk
Doxycycline Hyclate USP Tablets
Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed dissolution results.
Class II · Moderate risk
Doxycycline Hyclate Tablets
Failed Dissolution Specifications: Out of specification result for the dissolution test.
Class II · Moderate risk
Doxycycline Hyclate Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Doxycycline Hyclate Tablets
Failed Dissolution Specifications:
Class II · Moderate risk
Doxycycline Hyclate Tablets
Failed Dissolution Specifications:
Class III · Low risk
Diltiazem HCl Extended-Release Capsules
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Class III · Low risk
Diltiazem CD
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Class III · Low risk
Diltiazem HCl Extended-Release Capsules
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Class III · Low risk
Aptensio XR
Failed Dissolution Specification: Low dissolution outside of specifications
Class II · Moderate risk
Amantadine HCl Capsules
Failed Dissolution Specifications
Class III · Low risk
buPROPion HCl Extended-Release Tablets
Failed Dissolution Specifications; during stability testing
Class III · Low risk
buPROPion HCl Extended-Release Tablets
Failed Dissolution Specifications; during stability testing
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