Class II · Moderate risk
Nafcillin various strengths in sterile water for injection bags
Lack of sterility assurance.
FDA drug recalls in 2014
Every FDA drug recall initiated in 2014, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,309 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.