Class II · Moderate risk
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged…
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
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
Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged…
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Class III · Low risk
Xiidra (lifitegrast ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class III · Low risk
Xiidra (lifitegrast ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class III · Low risk
Xiidra (lifitegrast ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class III · Low risk
Xiidra (lifitegrast ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class II · Moderate risk
Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan HCTZ 50/12.5 mg
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan HCTZ 100/12.5 mg
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Class II · Moderate risk
Losartan HCTZ 100/25 mg
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Class II · Moderate risk
Losartan Potassium & Hydrochlorothiazide Tablets
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium & Hydrochlorothiazide Tablets
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium & Hydrochlorothiazide Tablets
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium Tab. USP 50mg
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Class II · Moderate risk
Rifampin for Injection
Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
Class II · Moderate risk
Losartan Potassium 50 mg Tablet
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Class II · Moderate risk
Esomeprazole Magnesium Delayed-Release Capsules
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Class II · Moderate risk
Esomeprazole Magnesium Delayed-Release Capsules
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Class II · Moderate risk
Travoprost Ophthalmic Solution
Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification results for related substance impurities/degradation during routine stability testing.
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets USP
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
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