Class II · Moderate risk Terminated
Linezolid various strengths in dextrose
Reason Lack of sterility assurance.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Levofloxacin various strengths in normal saline
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Ceftriaxone various strengths in normal saline
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Daptomycin various strengths in normal saline bags
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Gentamicin various strength in normal saline bags
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Tobramycin various strengths in normal saline bags
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Cefazolin various strengths in normal saline bags
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Nafcillin various strengths in sterile water for injection bags
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Meropenem various strengths in normal saline bags
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Cefuroxime various strengths in normal saline bags
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Vancomycin various strengths in normal saline bags
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Piperacillin/ tazobactam various strength in normal saline bags
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Ertapenem various strength in normal saline bags
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Imipenem/ cilastatin various strength in normal saline bags
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Ceftazidime various strength in normal saline bags
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Cefoxitin various strength in normal saline bags
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Cefepime various strengths in normal saline
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Aztreonam 1 gram in normal saline
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Amikacin various strength in normal saline bags
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Liposomal Amphotericin B 130 mg in dextrose bags
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Propofol Injectable Emulsion
Reason Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.
Class II · Moderate risk Terminated
Fluconazole Injection
Reason Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
Class II · Moderate risk Terminated
Benzonatate Capsules
Reason Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility: The product has the potential for solution to leak at the administrative port.
Class II · Moderate risk Terminated
B-Lipo
Reason Marketed without an Approved NDA/ANDA; found to contain Lorcaserin, a controlled substance used for weight loss