Class II · Moderate risk
Nafcillin various strengths in sterile water for injection bags
Lack of sterility assurance.
FDA Drug Recalls
1,273 recalls, newest first
Class II · Moderate risk
Meropenem various strengths in normal saline bags
Lack of sterility assurance.
Class II · Moderate risk
Cefuroxime various strengths in normal saline bags
Lack of sterility assurance.
Class II · Moderate risk
Vancomycin various strengths in normal saline bags
Lack of sterility assurance.
Class II · Moderate risk
Piperacillin/ tazobactam various strength in normal saline bags
Lack of sterility assurance.
Class II · Moderate risk
Ertapenem various strength in normal saline bags
Lack of sterility assurance.
Class II · Moderate risk
Imipenem/ cilastatin various strength in normal saline bags
Lack of sterility assurance.
Class II · Moderate risk
Ceftazidime various strength in normal saline bags
Lack of sterility assurance.
Class II · Moderate risk
Cefoxitin various strength in normal saline bags
Lack of sterility assurance.
Class II · Moderate risk
Cefepime various strengths in normal saline
Lack of sterility assurance.
Class II · Moderate risk
Aztreonam 1 gram in normal saline
Lack of sterility assurance.
Class II · Moderate risk
Amikacin various strength in normal saline bags
Lack of sterility assurance.
Class II · Moderate risk
Liposomal Amphotericin B 130 mg in dextrose bags
Lack of sterility assurance.
Class II · Moderate risk
Propofol Injectable Emulsion
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
Fluconazole Injection
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
Class II · Moderate risk
Benzonatate Capsules
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility: The product has the potential for solution to leak at the administrative port.
Class III · Low risk
ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP
Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.
Class I · High risk
Slim-K
Marketed Without An Approved NDA/ANDA: Product was found to contain sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling and analysis.
Class II · Moderate risk
B-Lipo
Marketed without an Approved NDA/ANDA; found to contain Lorcaserin, a controlled substance used for weight loss
Class III · Low risk
3M ESPE Clinpro 5000
Labeling: Incorrect or Missing Lot and/or Exp. Date - The subject lot is missing the lot number and expiration date stamp on the primary box..
Class I · High risk
Virginia Hospital Center
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Spotsylvania Regional Med Ctr
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Spotsylvania Regional Med Ctr
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Texas Health Presbyterian Dallas Neonatal Admit TPN 4 GM
Non-Sterility: Out of specification results for the sterility test for microbial contamination.