Veklury (remdesivir)
Presence of Particulate Matter: Presence of glass particle.
Every FDA drug recall initiated in 2024, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
557 recalls, newest first.
Presence of Particulate Matter: Presence of glass particle.
CGMP deviations
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.
Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Temperature abuse: Products exposed to improper temperature above drug label specifications.
cGMP Deviations: Temperature excursion
Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.
Lack of Assurance of Sterility
Failed Dissolution Specifications
Microbial Contamination of Non-Sterile Product
Subpotent Drug
Microbial contamination of non-sterile Products -
Discoloration
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
LABELING: LABEL MIX-UP.
Lack of Assurance of Sterility