Class II · Moderate risk
Adenosine-Mono-Phosphate Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Sterility & contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections.
6,317 FDA drug recalls with this cause, newest first.
This is the single biggest cause in the register by a wide margin. It covers products that had to be sterile - injectables, eye drops, certain ointments - but could not be verified sterile, or were found contaminated during testing. Most of these recalls come from compounding pharmacies and outsourcing facilities after an FDA inspection finds gaps in how sterile products were made. Sterility failures are treated seriously because the products involved have the least room for error, going straight into the bloodstream or the eye.
Class II · Moderate risk
Acepromazine 25 mg/ml Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Acetyl-D-Glucosamine w/Chondroitin 200 mg/ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Wydase 5ml
Lack of Assurance of Sterility
Class II · Moderate risk
Eyebright Concentrate Topical Eye Rinse
Lack of Assurance of Sterility; Lack of Assurance of Sterility; product not manufactured under sterile conditions as required for ophthalmic drug products
Class II · Moderate risk
Metronidazole Injection USP
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.
Class II · Moderate risk
Sodium Chloride Injection
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.
Class II · Moderate risk
Lidocaine Hydrochloride and 5% Dextrose Injection
Lack of Assurance of Sterilty: 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.
Class II · Moderate risk
Heparin Sodium and 0.9% Sodium Chloride Injection
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.
Class II · Moderate risk
5% Dextrose Injection
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.
Class II · Moderate risk
0.9% Sodium Chloride Injection
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.
Class II · Moderate risk
Diazepam Injection
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Class II · Moderate risk
Baxter LL bag 2% Amino Acids
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Baxter LL bag 1.5% Amino Acids
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Baxter LL bag 1% Amino Acids w/KCL
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Proplete 45 - 51 KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Proplete 90+ KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Proplete 80+ KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Proplete 70+ KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions
Class II · Moderate risk
Proplete 60 - 69 KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Proplete 52 - 59 KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Proplete 40 - 44 KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Idpn
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Fresenius bag 1% Amino Acids
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions
Class II · Moderate risk
Baxter LL bag 1% Amino Acids
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
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