Class III · Low risk
Suprax
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
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
Suprax
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Class III · Low risk
Zithromax (azithromycin for injection)
Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant.
Class II · Moderate risk
Hydralazine HCL Tablets
Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.
Class II · Moderate risk
Hydralazine HCL Tablets
Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.
Class III · Low risk
Cetirizine Hydrochloride Syrup
Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
Class III · Low risk
Folic Acid Injection
Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
Class III · Low risk
Ketoconazole Cream
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
Class II · Moderate risk
Quinapril Tablets USP
Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
Class II · Moderate risk
Quinapril Tablets USP
Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
Class II · Moderate risk
Lisinopril Tablets
Failed Impurities/Degradation Specifications: Out of Specification results for Individual Other Unknown Related Compounds were obtained at the 48 month time-point.
Class II · Moderate risk
Nystatin Oral Suspension
Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.
Class II · Moderate risk
VECURONIUM Bromide for Injection
CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed Impurities/Degradation Specifications as a high out of specification impurity result was detected during routine quality testing of stability samples.
Class III · Low risk
Fentanyl Transdermal System
Failed Impurities/Degradation Specifications
Class III · Low risk
Folic Acid Injection
Failed Impurities/Degradation Specification
Class II · Moderate risk
Enablex (darifenacin)
Failed Impurities/Degradation Specifications: unspecified degradation product
Class II · Moderate risk
Ranitidine Syrup
Failed Impurity/Degradation Specification; "Related Compound C"
Class III · Low risk
Excedrin
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
Class III · Low risk
Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Class III · Low risk
Theraflu Warming Relief
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
Class III · Low risk
Maximum Strength Comtrex
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Class III · Low risk
Maximum Strength Comtrex
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Class III · Low risk
Maximum Strength Comtrex Nighttime Cold & Cough
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Class III · Low risk
Maximum Strength Comtrex Day/Night Cold & Cough
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Class III · Low risk
Nicardipine Hydrochloride Injection 25 mg/10 mL
Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
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