Class II · Moderate risk Terminated
Accuretic
Reason CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Accuretic
Reason CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk Terminated
Orphenadrine Citrate Extended-Release Tablets
Reason CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Class II · Moderate risk Terminated
The Natural Dentist Healthy Breath Antiseptic Rinse
Reason 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 Terminated
Netspot
Reason Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
Class II · Moderate risk Terminated
Glycopyrrolate Tablets
Reason Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.
Class III · Low risk Terminated
Atorvstatin Calcium Tablets
Reason Failed Impurities/Degradation Specifications: Out of Specification results for related substance.
Class II · Moderate risk Terminated
Lidocaine Ointment USP
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk Terminated
Lidocaine Cream 4%
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk Terminated
Hydrocortisone Butyrate Lotion
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk Terminated
Gentamicin Sulfate Cream USP
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk Terminated
Diflorasone Diacetate Ointment USP
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk Terminated
Clobetasol Propionate Cream USP
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk Terminated
Triamcinolone Acetonide Ointment USP
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk Terminated
Triamcinolone Acetonide Lotion USP
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk Terminated
Triamcinolone Acetonide Cream USP
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk Terminated
Triamcinolone Acetonide Ointment USP
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk Terminated
Nystatin and Triamcinolone Acetonide Ointment
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk Terminated
Lidocaine Ointment USP
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk Terminated
Lidocaine Cream
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk Terminated
Hydrocortisone Butyrate Lotion
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk Terminated
Halobetasol Propionate Ointment
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk Terminated
Hydrocortisone Butyrate Lotion 0.1%
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk Terminated
Halobetasol Propionate Ointment
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk Terminated
Halobetasol Propionate Ointment
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.