Class II · Moderate risk
S-Dextrose/Glycerin/Phenol 25/25/2.5% Inj Soln
Lack of Assurance of Sterility
FDA Drug Recalls
1,563 recalls, newest first
Class II · Moderate risk
S-Cyanocobalamin 1
Lack of Assurance of Sterility
Class II · Moderate risk
S-Calm Injection
Lack of Assurance of Sterility
Class II · Moderate risk
S-Calcium Gluconate 10% Injection
Lack of Assurance of Sterility
Class II · Moderate risk
S-Calcium Chloride 100mg/Ml
Lack of Assurance of Sterility
Class II · Moderate risk
S-Benzalkonium Chloride 0.013% Solution
Lack of Assurance of Sterility
Class II · Moderate risk
S-B5/B6/B12m 100/50/10mg/Ml Mdv Soln
Lack of Assurance of Sterility
Class II · Moderate risk
S-Atropine 0.5% Opth Soln
Lack of Assurance of Sterility
Class II · Moderate risk
S-Atropine 0.02% Opthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
S-Atropine 0.01% Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
S-Ascorbic/Glutathione 1.25/1.25% Opth Soln
Lack of Assurance of Sterility
Class II · Moderate risk
S-Ascorbic Acid 500mg/Ml Mdv Soln
Lack of Assurance of Sterility
Class II · Moderate risk
S-Amitriptyline 10mg/Ml Mdv Inj Soln
Lack of Assurance of Sterility
Class II · Moderate risk
Soothing Sore Relief
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Class II · Moderate risk
Soothing Sore Relief
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Class II · Moderate risk
Superior Pain & Itch Relief
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Class II · Moderate risk
Superior Pain & Itch Relief
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Class II · Moderate risk
PRE-TAT (lidocaine)
Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.
Class II · Moderate risk
PRE-TAT (lidocaine)
Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.
Class II · Moderate risk
Carbamazepine
Failed Dissolution Specifications
Class II · Moderate risk
Vivitrol (naltrexone for extended-release injectable suspension)
Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.
Class III · Low risk
Clotrimazole and Betamethasone Dipropionate Cream USP
Temperature Abuse: Complaints received of liquidy texture.
Class III · Low risk
Eptifibatide Injection
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Class III · Low risk
Eptifibatide Injection
Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) and Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Class III · Low risk
Eptifibatide Injection
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.