Class III · Low risk
buPROPion Hydrochloride Extended-Release Tablets
Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.
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 II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Capsules
Failed Dissolution Specifications: Out-of-specification results in retained sample.
Class II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Capsules
Failed Dissolution Specifications: Out-of-specification results in retained sample.
Class III · Low risk
BuPROPion Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
Class II · Moderate risk
Venlafaxine HCL ER Capsule USP
Failed Dissolution Specifications: out of specification dissolution results in retained samples
Class II · Moderate risk
Venlafaxine HCL ER Capsule USP
Failed Dissolution Specifications: out of specification dissolution results in retained samples
Class II · Moderate risk
Dextroamphetamine Sulfate Extended-Release Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Glipizide 2.5 mg Extended-release tablets
Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
Class III · Low risk
buPROPion Hydrochloride Extended Release Tablets USP
Failed Dissolution Specifications
Class II · Moderate risk
Alprazolam Extended-release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Nitrofurantoin Oral Suspension
Failed Dissolution Specifications
Class III · Low risk
Intermezzo
Failed Dissolution Specifications
Class II · Moderate risk
Paliperidone Extended-release Tablets
Failed Dissolution Specifications; three month stability time point.
Class III · Low risk
Duloxetine Delayed-Release Capsules
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Class III · Low risk
Duloxetine Delayed-Release Capsules
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Class III · Low risk
Duloxetine Delayed-Release Capsules
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Class II · Moderate risk
Levofloxacin Tablets USP
Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.
Class II · Moderate risk
Capecitabine tablets USP 500 mg
Failed Dissolution Specifications: low test results at the 18 month time-point
Class III · Low risk
Norpace CR
Failed Dissolution Specification
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.
Class II · Moderate risk
Fenoglide (fenofibrate)
Failed Dissolution Specifications: Failed 24 month dissolution testing.
Class II · Moderate risk
Rivastigmine Tartrate Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Lisinopril Tablets
Failed Dissolution Specifications
Class III · Low risk
Dexmethylphenidate HCl Extended-Release
Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing.
Class II · Moderate risk
univasc (moexipril HCl)
Failed Dissolution Testing: Failed 24 month dissolution testing.
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