Class I · High risk
Epinephrine Injection
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
FDA Drug Recalls
4 recalls · Class I, newest first
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 I · High risk
Webcol Alcohol Prep pad
Non-Sterility: microbial contamination identified as Paenibacillus phoenicis