Class II · Moderate risk
Shiseido Future Solution LX Universal Defense SPF 50+
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
FDA Drug Recalls
1,356 recalls, newest first
Class II · Moderate risk
bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Class II · Moderate risk
Glenmark Mometasone Furoate Cream
CGMP Deviations: Market complaints related to "gritty texture".
Class II · Moderate risk
Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine
GMP Deviations: inadequate manufacturing control processes
Class II · Moderate risk
Extra Strength Naturally HL Liquid Hemorrhoid Relief Gel
GMP Deviations: inadequate manufacturing control processes
Class II · Moderate risk
Extra Strength Naturally HL Hemorrhoid Numbing Spray with Lidocaine
GMP Deviations: inadequate manufacturing control processes
Class II · Moderate risk
Extra Strength PreTAT by TAT BALM Gel
GMP Deviations: inadequate manufacturing control processes
Class II · Moderate risk
Extra Strength Naturally HL Bed Sore Relief Cream with Added Lidocaine
GMP Deviations: inadequate manufacturing control processes
Class II · Moderate risk
Estriol
cGMP Deviations: lack of quality assurance at the API manufacturer.
Class II · Moderate risk
TYVASO (treprostinil)
CGMP Deviations
Class I · High risk
PIYANPING Anti-Itch
Incorrect Product Formulation: product contains dexamethasone instead of hydrocortisone.
Class II · Moderate risk
Testosterone Cypionate + Progesterone
CGMP Deviations
Class II · Moderate risk
Chlorhexidine Gluconate 0.12% Oral Rinse
CGMP Deviations
Class II · Moderate risk
Methocarbamol
CGMP Deviations: Lack of quality assurance at the API manufacturer.
Class III · Low risk
Famotidine for Oral Suspension USP
CGMP Deviations
Class II · Moderate risk
Estradiol 6 mg pellet 99.5% Estradiol USP
CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk
Estradiol 10 mg pellet 99.5% Estradiol USP
CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk
Estradiol 12.5 mg pellet 99.5% Estradiol USP
CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk
Estradiol 15 mg pellet 99.5% Estradiol USP
CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk
Estradiol 18 mg pellet
CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk
Estradiol 20 mg pellet 99.5% Estradiol USP
CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk
Estradiol 22 mg pellet 99.5% Estradiol USP
CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk
Estradiol 25 mg pellet 99.5% Estradiol USP
CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk
Shield and Protect Moisture Barrier Cream
GMP Deviations; product may not meet cGMP requirements
Class II · Moderate risk
Estrone USP
cGMP Deviations; lack of quality assurance.