Class II · Moderate risk
Vial Label: 8.4% Sodium Bicarbonate Injection
Lack of Assurance of Sterility.
FDA Drug Recalls
721 recalls, newest first
Class II · Moderate risk
Vial Label: Epinephrine Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Class II · Moderate risk
Lactated Ringer's Injection USP
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Class II · Moderate risk
4.2% Sodium Bicarbonate Injection
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Class II · Moderate risk
Recombinate
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class I · High risk
NAD+ (Nicotinamide adenine dinucleotide)
Microbial Contamination of Sterile Products: elevated endotoxin levels
Class II · Moderate risk
Retatrutide for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Sermorelin Lyophilized powder for reconstitution
Lack of Assurance of Sterility
Class II · Moderate risk
Epithalon for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Tesamorelin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Thymosin Beta-4
Lack of Assurance of Sterility
Class II · Moderate risk
BPC-157/Thymosin Beta-4 for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
BPC-157 for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Zinc Chloride for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide with B12 for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Sterile Saline Reconstitution Solution for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Reconstitution XO Solution for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
pH Buffered Reconstitution Solution for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Proline for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Pentosan for Injection
Lack of Assurance of Sterility