Class III · Low risk
Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide)
Failed Impurities/Degradation Specifications
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
Cetirizine HCl Chewable Tablet
Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.
Class II · Moderate risk
Hydroxyzine Hydrochloride
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Hydroxyzine Hydrochloride
Failed Impurities/Degradation Specifications
Class III · Low risk
Fexofenadine Hydrochloride Tablets
Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound during routine stability testing
Class III · Low risk
Promethazine Vc With Codeine Syrup
Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.
Class II · Moderate risk
GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Class III · Low risk
Fexofenadine HCl Tablets
Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
Class III · Low risk
Air Compressed
Failed Impurities/Degradation Specification; out of specification results for carbon dioxide
Class II · Moderate risk
Ergoloid Mesylates
Failed Impurities/Degradation Specifications: during long-term stability testing.
Class III · Low risk
Oxecta (oxycodone HCl)
Failed Impurities/Degradation Specifications
Class III · Low risk
Oxecta (oxycodone HCl)
Failed Impurities/Degradation Specifications
Class III · Low risk
Fentanyl Citrate Inj.
Failed Impurities/Degradation Specifications; 12 month stability testing.
Class III · Low risk
ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP
Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.
Class III · Low risk
Triamcinolone Acetonide Lotion USP
Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point.
Class III · Low risk
Simvastatin Tablets
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Class III · Low risk
Simvastatin Tablets
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Class III · Low risk
Simvastatin Tablets
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Class II · Moderate risk
Cyproheptadine HCl Syrup
Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.
Class II · Moderate risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications: Out of specification for unknown impurities.
Class III · Low risk
candesartan cilexetil
Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity and total impurities.
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