Class II · Moderate risk
CVS Allergy Relief
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
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
CAREONE Allergy Relief
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk
berkley jensen
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk
basic+care
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk
basic+care
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk
amazon
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk
GoodSense Aller.Ease
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk
EQUALINE aller-ease fexofenadine hydrochloride tablets
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class III · Low risk
Erythromycin Topical Gel
Failed Impurities/Degradation Specifications
Class III · Low risk
Erythromycin Topical Solution USP
Failed Impurities/Degradation Specifications
Class III · Low risk
Phytonadione Tablets 5 mg
Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
Class III · Low risk
Phytonadione Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Mephyton (Phytonadione)
Failed Impurities/Degradation Specifications
Class III · Low risk
Atorvastatin Calcium Tablets
Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities
Class III · Low risk
Sirolimus Tablets 1 mg
Failed Impurities/Degradation Specifications
Class III · Low risk
Atorvastatin Calcium Tablets
Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities
Class III · Low risk
Hydrocodone Bitartrate and Homatropine Methlybromide tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Cephalexin for Oral Suspension
Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer for Individual Unidentified Impurity found during related substance test analysis of Cephalexin
Class II · Moderate risk
Flurandrenolide Ointment USP
Failed Impurities/Degradation Specifications:
Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Omeprazole Delayed Release Capsules
Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer
Class II · Moderate risk
Ganirelix Acetate Injection
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Omeprazole Delayed-Release Capsules
Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.
Class II · Moderate risk
Gabapentin Oral Solution
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
Class III · Low risk
Romidepsin Injecton
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
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