Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications; 9 month stability 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
Ranitidine Syrup
Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.
Class III · Low risk
Quinapril Tablets USP 5 mg
Failed Impurities/Degradation Specifications; Impurity A
Class III · Low risk
Meclizine Hydrochloride Tablets
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk
Meclizine Hydrochloride Tablets
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class II · Moderate risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.
Class III · Low risk
Meclizine Hydrochloride Tablets
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk
Magnesium Sulfate 7-Hydrate
Failed Impurities/Degradation Specifications: Out of specifications results for impurities.
Class III · Low risk
Epsom Salt
Failed Impurities/Degradation Specifications: Level of iron exceeds the limit set by the USP monograph for it (USP limit is NMT 0.5 ug/g (ppm)).
Class III · Low risk
Meclizine Hydrochloride Tablets USP
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk
Meclizine Hydrochloride Tablets
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk
Amidate (Etomidate Injection, USP)
Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability testing.
Class III · Low risk
Cetirizine HCl 10 mg Tablet
Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester
Class III · Low risk
Rifampin for Injection USP
Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.
Class III · Low risk
Topicort (desoximetasone)
Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.
Class III · Low risk
Phentermine Hydrochloride Capsules
Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Class III · Low risk
Phentermine Hydrochloride Capsules
Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Class II · Moderate risk
Nitroglycerin Transdermal System 0.4 mg/hr
Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing.
Class II · Moderate risk
Nitroglycerin Transdermal System 0.2 mg/hr
Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24 month stability testing.
Class II · Moderate risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications: out of specification for unknown impurity
Class II · Moderate risk
Rifampin for Injection
Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation
Class III · Low risk
Fentanyl Citrate Inj.
Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
Class III · Low risk
QVAR (beclomethasone dipropionate HFA 40 mcg)
Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing.
Class III · Low risk
Levalbuterol Inhalation Solution
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Class III · Low risk
Chlordiazepoxide HCl/Clidinium Bromide capsules
Failed Impurities/Degradation Specifications
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