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.
FDA Drug Recalls
1,018 recalls, newest first
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 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.
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
Halobetasol Propionate Ointment
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 0.1%
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Halobetasol Propionate Ointment
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Halobetasol Propionate Ointment
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Gentamicin Sulfate Ointment USP 0.1%
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
Fluocinonide Topical Solution USP
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Fluocinonide Gel USP
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.