Class II · Moderate risk
Glycopyrrolate Tabs
Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity.
Impurities & degradation products
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present.
704 FDA drug recalls with this cause, newest first.
Every drug has a specification for how much of each impurity or breakdown product it may contain. These recalls are lots that exceeded one of those limits - often a related compound formed during manufacturing or storage, or an out-of-specification result found during routine stability testing. Nitrosamine impurities are common enough to get their own category; everything else lands here.
Class II · Moderate risk
Dutasteride Capsules
Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
Class II · Moderate risk
Sumatriptan Succinate Tablets
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Class II · Moderate risk
Sumatriptan Succinate Tablets
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Class III · Low risk
Bimatoprost Ophthalmic Solution
Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
Class II · Moderate risk
Estriol
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Class II · Moderate risk
Estriol
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Class II · Moderate risk
Estriol
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Class II · Moderate risk
Estriol
Failed Impurities/Degradation Specifications
Class III · Low risk
Isotretinoin Capsules
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
Class II · Moderate risk
Rifampin for Injection
Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product.
Class II · Moderate risk
Prednisolone Sodium Phosphate Oral Solution
Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14
Class II · Moderate risk
Oxcarbazepine Oral Suspension
Failed Impurities/Degradation Specificattion
Class II · Moderate risk
Anagrelide Capsules
Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
Class III · Low risk
Gatifloxacin Ophthalmic Solution 0.5%
Failed Impurities/Degradation Specifications:OOS for unknown impurity.
Class II · Moderate risk
Fexofenadine HCl Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Allergy (Fexofenadine Hydrochloride)
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Wal-Fex (Fexofenadine Hydrochloride)
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Allergy (Fexofenadine Hydrochloride)
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Fexofenadine HCL Tablets USP
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Fexofenadine Hydrochloride Tablets USP
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Allergy Relief
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Fexofenadine Hydrochloride Tablets USP
Failed Impurities/Degradation Specifications
Class II · Moderate risk
fexofenadine hydrochloride tablets USP
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Allergy Relief
Failed Impurities/Degradation Specifications
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