Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets USP
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 Potassium and Hydrochlorothiazide Tablets USP
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium Tablets USP
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium Tablets USP
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium Tablets USP
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class III · Low risk
Atorvstatin Calcium Tablets
Failed Impurities/Degradation Specifications: Out of Specification results for related substance.
Class II · Moderate risk
hydrALAZINE HCl Tablets
Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
Class II · Moderate risk
Oxycodone Hydrochloride Oral Solution
Impurity failure at 0-time of the repackaged lot.
Class II · Moderate risk
Dexamethasone Elixir
Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
Class II · Moderate risk
Moxifloxacin Ophthalmic Solution USP 0.5%
Failed impurities/degradation specifications
Class II · Moderate risk
Diazepam Oral Solution
Failed Impurities/Degradation Specifications: Out of specification results for related substances.
Class II · Moderate risk
Erythromycin Topical Gel USP
Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.
Class II · Moderate risk
Moxifloxacin Ophthalmic Solution
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Cefixime 400 mg capsule
Failed Impurities/Degradation Specifications
Class III · Low risk
Oxycodone Hydrochloride Tablets
Out-of-specification impurity test result observed at 18-month long term stability time point.
Class II · Moderate risk
Cefixime Capsules
Failed impurities/degradation specifications
Class III · Low risk
Carvedilol Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Cefixime Capsules 400 mg
Failed Impurities/Degradation Specifications
Class III · Low risk
Clonidine Transdermal System
Failed Impurities/Degradation Specifications
Class III · Low risk
Rizatriptan Benzoate Orally Disintegrating Tablets 10mg
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Class III · Low risk
Rizatriptan Benzoate Orally Disintegrating Tablets 5mg
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Class III · Low risk
Rizatriptan Benzoate Film Coated Tablets
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Class II · Moderate risk
Sodium Phenylbutyrate Powder
Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications; out of specification for Related Compound
Class III · Low risk
Glycopyrrolate Injection
Failed Impurities/Degradation Specifications
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