Class II · Moderate risk
Ciclopirox Shampoo
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
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 III · Low risk
Clindamycin Phosphate USP
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Class II · Moderate risk
Ganirelix Acetate Injection
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Class II · Moderate risk
Bromocriptine Mesylate Capsules
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
Class III · Low risk
Fesoterodine Fumarate
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Class III · Low risk
Everolimus tablets 2.5 mg
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Class III · Low risk
Everolimus tablets 10 mg
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Class III · Low risk
Everolimus tablets 7.5mg
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Class III · Low risk
Everolimus tablets 5mg
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Class II · Moderate risk
Gabapentin Capsules
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Class II · Moderate risk
Gabapentin Capsules
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Class II · Moderate risk
Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Class II · Moderate risk
Entecavir Tablets
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Class II · Moderate risk
Entecavir Tablets
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Class III · Low risk
Everolimus tablets 5mg
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Class II · Moderate risk
Entecavir Tablets
Failed Impurity/Degradation Specifications
Class II · Moderate risk
Entecavir Tablets
Failed Impurity/Degradation Specifications
Class II · Moderate risk
Viorele
Failed Impurities/Degradation Specifications
Class III · Low risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications:
Class III · Low risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications:
Class III · Low risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications:
Class III · Low risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications:
Class III · Low risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications:
Class II · Moderate risk
Succinylcholine Chloride Injection
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
Class II · Moderate risk
4.2% Sodium Bicarbonate Injection
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
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