Class II · Moderate risk
Betamethasone Dipropionate Lotion USP
Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
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
Sodium Phenylbutyrate POWDER
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Class II · Moderate risk
Fexofenadine Hydrochloride Tablets
Failed Impurities/Degradation Specifications
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
CVS Allergy Relief
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk
Kirkland Aller-Fex
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk
amazon basic+care
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk
Wal-Fex Fexofenadine Hydrochloride tablets
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk
Wal-Fex Fexofenadine Hydrochloride tablets
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk
up&up allergy relief
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk
TopCare Allergy Relief
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk
TopCare Allergy Relief
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk
Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk
Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk
Perrigo Fexofenadine Hydrochloride tablets
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk
Perrigo Fexofenadine Hydrochloride tablets
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk
allergyrelief
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk
Meijer allergy relief
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk
Major
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk
Kroger Allergy Relief
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk
H.E.B Allergy Relief
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk
H.E.B Allergy Relief
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk
Health Mart
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk
Health Mart
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk
DG/health Aller.Ease
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
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