Class I · High risk Terminated
Adventure First Aid 1.0
Reason Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
FDA Drug Recalls
1,739 recalls · Class I, newest first
Class I · High risk Terminated
Adventure Marine 150
Reason Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Class I · High risk Terminated
Easy Care first aid Burn Cream
Reason Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Class I · High risk Terminated
Vancomycin Hydrochloride for Injection
Reason Presence of Particulate Matter: Glass particulate matter detected in injectable.
Class I · High risk Terminated
Epinephrine
Reason Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Class I · High risk Terminated
Epinephrine
Reason Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Class I · High risk Terminated
Advil Liqui Gels
Reason Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Class I · High risk Terminated
Advil Liqui Gels
Reason Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Class I · High risk Terminated
Advil
Reason Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Class I · High risk Terminated
Iohexol
Reason Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
Class I · High risk Terminated
Daptomycin for Injection 350 mg/vial 1 Single-dose vial
Reason Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
Class I · High risk Terminated
8.4% Sodium Bicarbonate Injection
Reason Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Class I · High risk Terminated
8.4% Sodium Bicarbonate Injection
Reason Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Class I · High risk Ongoing
Adam's Polishes ALCOHOL BASED HAND SANITIZER
Reason Chemical Contamination: FDA analysis found 1 lot of Adam's Polishes ALCOHOL BASED HAND SANITIZER isopropyl alcohol 75% v/v to contain methanol.
Class I · High risk Terminated
Octreotide Acetate Injection 500 mcg/mL
Reason Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
Class I · High risk Terminated
8.4% Sodium Bicarbonate Injection
Reason Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Class I · High risk Terminated
8.4% Sodium Bicarbonate Injection
Reason Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Class I · High risk Terminated
Atenolol Tablets
Reason Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets
Class I · High risk Terminated
Antica Farmacista Hand Sanitizer Ocean Citron
Reason Chemical Contamination: product found to contain benzene
Class I · High risk Terminated
PROPOFOL Injectable Emulsion
Reason Presence of particulate matter
Class I · High risk Terminated
Banana Boat hair & scalp defense
Reason Chemical contamination: presence of benzene
Class I · High risk Terminated
SANGTER Energy Supplement Capsules
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil.
Class I · High risk Terminated
Sustango
Reason Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.
Class I · High risk Terminated
Walgreens
Reason Microbial contamination of non-sterile products.
Class I · High risk Terminated
Walgreens
Reason Microbial contamination of non-sterile products.