Estradiol 10mg pellet
Lack of Assurance of Sterility
Every FDA drug recall initiated in 2018, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,681 recalls, newest first.
Lack of Assurance of Sterility
Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine
Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.