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.
Failed impurities/degradation specification: An out of specification results has been determined for an individual related substance during stability testing at the 18th month interval for the Famotidine 10 mg Tablet, USP.
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
Failed Impurities/Degradation Specifications; 12 month stability time point
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification results for an unknown impurity at or near the expiration (24-month).
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.
Failed Impurities/Degradation Specifications: Out of specification test results for impurities during stability testing.
Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)
Failed Impurities/Degradation Specifications: Out of specification for a known degradant.
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