Class II · Moderate risk Terminated
Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator
Reason Short Fill
FDA Drug Recalls
17,898 recalls, newest first
Class III · Low risk Terminated
FentaNYL Citrate 2.5mg/50mL
Reason Short Fill: Underfilled units.
Class II · Moderate risk Terminated
Sterile Water for Injection
Reason CGMP Deviations: potential for trace amounts of product carryover.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection
Reason CGMP Deviations: potential for trace amounts of product carryover.
Class II · Moderate risk Terminated
Allopurinol Tablets USP
Reason Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Class II · Moderate risk Terminated
Metoprolol Succinate Extended-Release Tablets
Reason Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.
Class II · Moderate risk Ongoing
Humatrix Microclysmic Gel
Reason CGMP Deviations: initiated due to violations of CGMP manufacturing practices
Class II · Moderate risk Ongoing
Techni-Care Chloroxylenold 3%
Reason CGMP Deviations: initiated due to violations of CGMP manufacturing practices
Class II · Moderate risk Terminated
Rocuronium Bromide Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Metoprolol Succinate Extended-Release Tablets
Reason Failed Dissolution Specification
Class II · Moderate risk Terminated
Metoprolol Succinate Extended-Release Tablets
Reason Failed Dissolution Specification
Class II · Moderate risk Terminated
Metoprolol Succinate Extended-Release Tablets
Reason Failed Dissolution Specification
Class III · Low risk Terminated
Levofloxacin Tablets
Reason Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Class III · Low risk Terminated
Sinuva
Reason Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
Class II · Moderate risk Terminated
TriMix Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
BiMix STD 001
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
QuadMix Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
TriMix Plus 002
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
BiMix Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
TriMix Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
QuadMix Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Methylcobalamin Injection Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
TriMix Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
TriMix Plus 001
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
TriMix Injection
Reason Lack of Assurance of Sterility