Class II · Moderate risk
Lid O Creme
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
FDA drug recalls in 2019
Every FDA drug recall initiated in 2019, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,788 recalls, newest first.
Class II · Moderate risk
Lido E.R. (Lidocaine HCL 4%)
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk
Dermanak original crema blanqueador
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk
LidoAID (Lidocaine HCL 4%)
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk
Double Tussin Dm
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk
Gencontuss
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk
ARMY HEALTH Pain Reliever Gel With CURCUMIN
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk
Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk
ARMY HEALTH With CURCUMIN
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk
AbeeMed cream
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk
Oliver's Harvest CBD+Capsaicin 0.2% Pain Relief
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk
Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Class II · Moderate risk
Losartan Potassium Tablets 50 mg 1000 Tablets
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Class II · Moderate risk
Zinc Sulfate 1mg/Ml Injection Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Zinc Sulfate 1mg/Ml Injection Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin B Complex 100
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin B Complex 100
Lack of Assurance of Sterility
Class II · Moderate risk
Turbo Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Turbo Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Turbo Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Turbo Caine 2.5
Lack of Assurance of Sterility
Class II · Moderate risk
Travasol 10%
Lack of Assurance of Sterility