Every FDA drug recall initiated in 2013, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
2,085 recalls, newest first.
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot
Presence of Particulate Matter: Found during examination of retention samples.
Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Failed Impurities/Degradation Specifications: unspecified degradation product
Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets contained a trace amount of Methocarbamol.
Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks comprised of degraded organic material on tablets.
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Failed Impurity/Degradation Specification; "Related Compound C"
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.