Class III · Low risk
Liothyronine Sodium Tablets
Failed Impurities/Degradation Specifications: 3 month stability testing.
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
Ethambutol Hydrochloride Tablets USP
Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
Class II · Moderate risk
Meprobamate
Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .
Class II · Moderate risk
Meprobamate
Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .
Class III · Low risk
Femtrace 0.45 mg
Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
Class III · Low risk
Femtrace 0.9 mg
Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
Class III · Low risk
Caziant (desogestrel and ethinyl estradiol)
Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities.
Class II · Moderate risk
Temodar (temozolomide)
Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected during stability monitoring.
Class III · Low risk
Perindopril Erbumine Tablets
Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
Class II · Moderate risk
Oxygen
Failed impurities/degradation specifications: Purity readings for oxygen were out of specification.
Class II · Moderate risk
Arranon (nelarabine)
Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.
Class III · Low risk
Children's Cetirizine HCl Chewable Tablets 5 mg
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Class III · Low risk
Pramipexole Dihydrochloride Tablets
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Class III · Low risk
Pramipexole Dihydrochloride Tablets
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Class III · Low risk
Prometh VC with Codeine Cough Syrup
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Class III · Low risk
Prometh VC Plain
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Class III · Low risk
Fougera Ketoconazole Cream 2%
Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant product
Class III · Low risk
Hydroxyzine Hydrochloride Oral Solution
Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.
Class III · Low risk
HYDROCORTISONE and ACETIC ACID OTIC SOLUTION
Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.
Class III · Low risk
Famotidine Tablets USP
Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.
Class II · Moderate risk
Diazepam Injection
Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam.
Class III · Low risk
Caziant (desogestrel and ethinyl estradiol)
Impurities/Degradation Products: High Out-of-specification results were obtained for both known and unknown impurities.
Class III · Low risk
Leukine sargramostim 5 x 500 mcg/mL vial
Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point.
Class II · Moderate risk
Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL
Impurities/Degradation Products: exceeded specification at 3 month stability testing
Class III · Low risk
Morton
Impurities/Degradation Products: The product was found to contain a slightly out of specification level of bromides, exceeding the bromides limit for USP Sodium Chloride.
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