Class II · Moderate risk
Lovastatin Tablets USP
Failed Dissolution Specifications: Low out of specification results for dissolution during annual 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 III · Low risk
Duloxetine Delayed-Release Capsules USP
Failed Dissolution Specification
Class II · Moderate risk
Liothyronine Sodium Tablets
Failed Dissolution Specifications.
Class II · Moderate risk
Dutasteride and Tamsulosin HCl Capsules
Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
Class III · Low risk
Methylphenidate Hydrochloride Tablets USP
Failed Dissolution Specifications: Low out of specification results for dissolution.
Class III · Low risk
Quillivant XR methylphenidate HCl
Failed Dissolution Specifications
Class III · Low risk
Quillivant XR methylphenidate HCl
Failed Dissolution Specifications
Class III · Low risk
Paroxetine Extended-Release Tablets USP
Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
Class I · High risk
Paliperidone Extended-Release Tablets
Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one tablet. Teva cannot at this time exclude the potential for additional tablets to be below specification.
Class III · Low risk
PONSTEL (Mefanamic Acid)
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
Class III · Low risk
Mefenamic Acid
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
Class II · Moderate risk
Zenatane (isotretinoin)
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Class II · Moderate risk
Zenatane (isotretinoin)
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Class II · Moderate risk
Zenatane (isotretinoin)
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Class II · Moderate risk
Zenatane (isotretinoin)
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Class II · Moderate risk
Divalproex Sodium Delayed Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Divalproex Sodium Delayed Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Divalproex Sodium Delayed Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Divalproex Sodium Delayed Release Tablets
Failed Dissolution Specifications; 9 month long term stability
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Oral Suspension
Failed Dissolution Specifications
Class III · Low risk
Quillivant XR
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Class III · Low risk
Quillivant XR
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Class III · Low risk
Quillivant XR
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Class III · Low risk
Risedronate Sodium Delayed-release Tablets
Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.
Class III · Low risk
Zenatane (isotretinoin)
Failed dissolution specifications - low dissolution results at S3 stage.
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