Class I · High risk
Ceftriaxone for Injection USP
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
FDA drug recalls in 2018
Every FDA drug recall initiated in 2018, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,681 recalls, newest first.
Class I · High risk
Ceftriaxone for Injection USP
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Class I · High risk
Ceftriaxone for Injection USP
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Class I · High risk
Ceftriaxone for Injection USP
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Class III · Low risk
Temozolomide Capsules
Failed Dissolution Specifications
Class III · Low risk
Temozolomide Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Oxygen
CGMP Deviations
Class II · Moderate risk
Olmesartan Medoxomil and Hydrochlorothiazide Tablets
Failed dissolution specifications
Class II · Moderate risk
Cidofovir Dihydrate
CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Class II · Moderate risk
Folic Acid
Lack of sterility assurance.
Class II · Moderate risk
Zinc Sulfate
Lack of sterility assurance.
Class II · Moderate risk
Glycyrrhizic Acid
Lack of sterility assurance.
Class II · Moderate risk
Dexpanthenol
Lack of sterility assurance.
Class II · Moderate risk
Lysine HCl
Lack of sterility assurance.
Class II · Moderate risk
Leucine/Isoleucine/Valine injection
Lack of sterility assurance.
Class II · Moderate risk
Pyridoxine HCl
Lack of sterility assurance.
Class II · Moderate risk
Procaine HCl
Lack of sterility assurance.
Class II · Moderate risk
Trim Calm
Lack of sterility assurance.
Class II · Moderate risk
Folic Acid
Lack of sterility assurance.
Class II · Moderate risk
Zinc Sulfate
Lack of sterility assurance.
Class II · Moderate risk
Myer's Cocktail
Lack of sterility assurance.
Class II · Moderate risk
Niacinamide injection
Lack of sterility assurance.
Class II · Moderate risk
Nicotinamide Adenine Dinucleotide
Lack of sterility assurance.
Class II · Moderate risk
MIC B12+L-Carnitine+Chromium injection
Lack of sterility assurance.
Class II · Moderate risk
ICB-Complex
Lack of sterility assurance.