Class II · Moderate risk
Azacitidine for Injection 100mg/Vial
Lack of Sterility Assurance
FDA Drug Recalls
117 recalls, newest first
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.