Class III · Low risk
Buprenorphine Transdermal System
Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-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
Buprenorphine Transdermal System
Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
Class II · Moderate risk
Warfarin Sodium Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Allergy Relief
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Picnic
Failed Impurities/Degradation Specifications
Class II · Moderate risk
allergy relief
Failed Impurities/Degradation Specifications
Class II · Moderate risk
allergyrelief
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Fexofenadine Hydrochloride Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Fexofenadine Hydrochloride Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
allergy relief
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Allergy ALLER-FEX
Failed Impurities/Degradation Specifications
Class II · Moderate risk
aller-ease
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Allergy Relief
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Allergy Relief
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Non-Drowsy Allergy Relief
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Allergy
Failed Impurities/Degradation Specifications
Class III · Low risk
Bd-102 Nf
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk
Avicel PH-200 NF
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk
Avicel PH- 102 NF
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk
Avicel PH- 101 NF
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class II · Moderate risk
Posaconazole Delayed-Release Tablets
Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
Class II · Moderate risk
BuPROPion Hydrochloride Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Glycopyrrolate Tablets
Failed impurities/degradation specifications: Out of specification for unknown impurities.
Class II · Moderate risk
Rifampin Capsules USP
Failed Impurities/Degradations Specifications
Class II · Moderate risk
Rifampin Capsules
Failed Impurities/Degradation specifications
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