Class III · Low risk
Paricalcitol Capsules
Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufacturer due to failed results for impurities.
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
Clonazepam Tablets
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.
Class III · Low risk
Clonazepam Tablets
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.
Class III · Low risk
PARICALCITOL Capsules
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Class III · Low risk
PARICALCITOL Capsules
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Class III · Low risk
PARICALCITOL Capsules
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Class III · Low risk
mitoXANTRONE Injection USP
Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
Class III · Low risk
Cytotec (misoprostol)
Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
Class III · Low risk
Claravis (isotretinoin capsules USP)
Failed Impurities/Degradation Specifications.
Class III · Low risk
Hydrocortisone and acetic acid otic solution
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).
Class III · Low risk
Acetasol HC
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).
Class III · Low risk
Desoximetasone Gel USP
Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point
Class III · Low risk
Carvediol Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Carvediol Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Carvediol Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Carvediol Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Sirolimus Tablets
Failed impurities/degradation: out of specification result for impurity secorapamycin.
Class III · Low risk
Ciprofloxacin OPTH 0.3% SOL
Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.
Class II · Moderate risk
Chlorhexidine Gluco. 0.12% Oral Rinse
Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.
Class III · Low risk
mitoXANTRONE Injection USP
Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
Class III · Low risk
Pramipexole Dihydrochloride Extended Release Tablets
Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above currently approved specification levels.
Class III · Low risk
Oxycodone HCl
Failed Impurities/Degradation Specification; 9 month stability
Class II · Moderate risk
Bromocriptine Mesylate Capsules USP
Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree Celsius /65% RH) stability samples of two batches.
Class III · Low risk
Dicloxacillin Sodium Capsules USP
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Class III · Low risk
Dicloxacillin Sodium Capsules
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
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