Class III · Low risk
Allergy Relief D Fexofenadine HCl
Failed dissolution specifications
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
12 HR Allergy & Congestion Relief Fexofenadine HCl
Failed dissolution specifications
Class III · Low risk
Antihistamine & Nasal Decongestant
Failed dissolution specifications
Class III · Low risk
Antihistamine & Nasal Decongestant
Failed dissolution specifications
Class III · Low risk
Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended…
Failed dissolution specifications
Class III · Low risk
Allergy & Congestion Relief Allergy Relief D
Failed dissolution specifications
Class III · Low risk
Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl…
Failed dissolution specifications
Class II · Moderate risk
Imipramine Pamoate Capsules 125 mg
Out of specification result observed in a dissolution test at the 9-month long term stability time point.
Class II · Moderate risk
Potassium Chloride Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
GlipiZIDE Extended-Release Tablets
Failed Dissolution Specifications: results were above specification.
Class II · Moderate risk
Lyrica CR (pregabalin)
Failed Dissolution Specifications
Class II · Moderate risk
Carbamazepine 200mg Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Entacapone Tablets
Failed Dissolution Specifications
Class II · Moderate risk
NIFEdipine EXTENDED-RELEASE TABLETS
Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
Class II · Moderate risk
Itraconazole Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Progesterone Capsules
Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.
Class II · Moderate risk
Imatinib Mesylate Tablets 100mg
Failed Dissolution Specifications
Class II · Moderate risk
Meclizine HCl Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Meclizine HCl Tablets
Failed Dissolution Specifications
Class III · Low risk
Auryxia (ferric citrate)
Failed Dissolution Specifications
Class II · Moderate risk
Nitrofurantoin Capsules USP
Failed Dissolution Specifications
Class II · Moderate risk
Vumerity (diroximel fumarate)
Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
Class II · Moderate risk
Lansoprazole Delayed-Release Orally Disintegrating Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg
Failed Dissolution Specifications
Class I · High risk
Anagrelide Capsules
Failed Dissolution Specifications
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