Class II · Moderate risk
Azacitidine for Injection 100mg/Vial
Lack of Sterility Assurance
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
Bortezomib for Injection 3.5mg/Vial
Lack of Sterility Assurance
Class II · Moderate risk
Pemetrexed for Injection 500mg/Vial
Lack of Sterility Assurance
Class II · Moderate risk
Pemetrexed for Injection 100mg/Vial
Lack of Sterility Assurance
Class II · Moderate risk
BD ChloraPrep CLear
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
BD ChloraPrep CLear
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
BD ChloraPrep Scrub Teal
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
BD ChloraPrep Scrub Teal
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
BD ChloraPrep Hi-Lite Orange
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
BD ChloraPrep Hi-Lite Orange
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
ChloraPrep FREPP
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
BD ChloraPrep Clear
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
BD PurPrep
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
BD ChloraPrep Hi-Lite Orange
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
Imuldosa
Lack of assurance of Sterility:
Class II · Moderate risk
Lidocaine HCl Injection USP
Lack of Assurance of Sterility
Class II · Moderate risk
Accucaine
Lack of Assurance of Sterility
Class I · High risk
BD ChloraPrep FREPP Clear
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Class I · High risk
BD ChloraPrep Clear
Non-Sterility: Due to presence of Aspergillus penicillioides.
Class II · Moderate risk
BD ChloraPrep FREPP Clear
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Class II · Moderate risk
BD ChloraPrep Clear
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Class II · Moderate risk
PReye Vitamin See Antioxidant Preservative Free Eye Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine HCl Injection USP
Lack of Assurance of Sterility
Class II · Moderate risk
cimzia (certolizumab pegol)
Lack of Assurance of Sterility
Class II · Moderate risk
Oasis Tears PF
Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.
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