Class II · Moderate risk Terminated
Secret OUTLAST Dry Spray
Reason CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
FDA Drug Recalls
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Class II · Moderate risk Terminated
Secret
Reason CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class I · High risk Terminated
Secret
Reason Chemical contamination: presence of benzene
Class II · Moderate risk Terminated
Secret
Reason CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class I · High risk Terminated
Secret
Reason Chemical contamination: presence of benzene
Class I · High risk Terminated
Secret
Reason Chemical contamination: presence of benzene
Class I · High risk Terminated
Secret
Reason Chemical contamination: presence of benzene
Class I · High risk Terminated
Old Spice
Reason Chemical contamination: presence of benzene
Class I · High risk Terminated
Old Spice
Reason Chemical contamination: presence of benzene
Class II · Moderate risk Terminated
Old Spice
Reason CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class I · High risk Terminated
Old Spice
Reason Chemical contamination: presence of benzene
Class II · Moderate risk Terminated
Hydrocodone Bitartrate and Acetaminophen Tablets
Reason Product Mix-up
Class III · Low risk Terminated
Tydemy
Reason Subpotent Drug
Class II · Moderate risk Terminated
Ascorbic Acid Solution for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Biotin Solution for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Methylcobalamin Solution for Injection
Reason Lack of Assurance of Sterility
Class I · High risk Terminated
Odor-Eaters Spray Powder
Reason Chemical contamination: Presence of benzene
Class III · Low risk Terminated
Carvedilol Tablets
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Sodium Bicarbonate in 5% Dextrose Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
PHENYLephrine HCl
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
PHENYLephrine HCl
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Norepinephrine
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Norepinephrine
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Norepinephrine
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Norepinephrine
Reason Lack of Assurance of Sterility