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.
FDA Drug Recalls
18,003 recalls, newest first
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.
Class I · High risk
Bayshore Medical Center
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Bayshore Medical Center
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Lankenau Hospital
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Abington Memorial Hospital
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Abington Memorial Hospital
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Abington Memorial Hospital
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Virtua West Jersey Voorhees
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Robert Wood Johnson University
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Robert Wood Johnson University
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Hackensack University Med Ctr
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
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
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.