Class I · High risk
Truman Medical Center Lakewood
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
FDA Drug Recalls
5,405 recalls, newest first
Class I · High risk
Truman Medical Center Lakewood
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
St Lukes East Lees Summit
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Providence Hospital Southfield
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Walter Reed Natl Mil Med Ctr
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Walter Reed Natl Mil Med Ctr
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Sinai Hospital
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Holy Cross Hospital
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Olathe Medical Center
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Methodist Hospital Northlake
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Advocate Good Samaritan Hospital
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Advocate Good Samaritan Hospital
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Adventist Hinsdale Hospital
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Adventist Hinsdale Hospital
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Bridgeport Hospital
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
The Medical Center of Aurora
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Rose Medical Center
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Rose Medical Center
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Children's Hospital Colorado Springs TPN Neonate Starter Bag 4% AA/10% DEX
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
University of Alabama Birmingham TPN Neonatal Starter Bag
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class II · Moderate risk
Fentanyl Citrate Injection
Lack of Assurance of Sterility; improperly crimped fliptop vials
Class II · Moderate risk
Clinimix E 4.25/10 sulfite-free
Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal
Class II · Moderate risk
Sodium Tetradecyl SO4 0.3% Inj.
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
Hcg - 10
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
Tri Mix PF SYR 0.5 mL Inj.
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.