Class II · Moderate risk
Accuretic (quinapril HCl/hydrochlorothiazide)
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
FDA drug recalls in 2022
Every FDA drug recall initiated in 2022, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,390 recalls, newest first.
Class II · Moderate risk
Accuretic (quinapril HCl/hydrochlorothiazide)
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk
Accuretic (quinapril HCl/hydrochlorothiazide)
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk
Orphenadrine Citrate Extended-Release Tablets
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Class II · Moderate risk
The Natural Dentist Healthy Breath Antiseptic Rinse
Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Peppermint Oil and Sage Oil and has the wrong UPC
Class III · Low risk
NETSPOT (kit for the preparation of Ga 68 dotatate injection)
Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
Class II · Moderate risk
Glycopyrrolate Tablets
Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.
Class II · Moderate risk
Enalapril Maleate Tablets
CGMP Deviations
Class II · Moderate risk
Enalapril Maleate Tablets
CGMP Deviations
Class II · Moderate risk
Enalapril Maleate Tablets
CGMP Deviations
Class II · Moderate risk
Enalapril Maleate Tablets
CGMP Deviations
Class III · Low risk
Atorvstatin Calcium Tablets
Failed Impurities/Degradation Specifications: Out of Specification results for related substance.
Class II · Moderate risk
Lidocaine Ointment USP
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Lidocaine Cream 4%
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Hydrocortisone Butyrate Lotion
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Gentamicin Sulfate Cream USP
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Diflorasone Diacetate Ointment USP
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Clobetasol Propionate Cream USP
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Triamcinolone Acetonide Ointment USP
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Triamcinolone Acetonide Lotion USP
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Triamcinolone Acetonide Cream USP
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Triamcinolone Acetonide Ointment USP
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Nystatin and Triamcinolone Acetonide Ointment
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Lidocaine Ointment USP
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Lidocaine Cream
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.