ADRUCIL (fluorouracil injection, USP)
Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution
Every FDA drug recall initiated in 2015, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,733 recalls, newest first.
Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution
Failed Dissolution Testing: Failed 24 month dissolution testing.
Failed Dissolution Specifications
Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry