Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme…
Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine
1,590 recalls, newest first
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.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.