Class II · Moderate risk Terminated
Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme…
Reason Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine
FDA Drug Recalls
14,801 recalls, newest first
Class III · Low risk Terminated
Metoprolol Tartrate Injection
Reason Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
Class II · Moderate risk Terminated
Cidofovir injection 375 mg/mL
Reason Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle
Class II · Moderate risk Terminated
HydrOXYzine HYDROCHLORIDE SYRUP
Reason CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
Class II · Moderate risk Terminated
Diet Power
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
Body Balance
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
Acne Tonic Homeopathic Oral Spray 1.38 fl. oz.
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
Body Skin Tonic
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
ImmunoBooster
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
Life Detoxer Homeopathic Oral Spray 1.38 fl. oz.
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
PMS Support
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
Stress Relief
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
Snore Soother
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
Arnica Power
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
Party Relief
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
TravelEase
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
SleepEase
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
DigestivEase
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
Cold + Flu Relief
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
AllergEase
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
Bone Builder
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
MenoPower
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
Woman Power
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
Brain Power
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
Man Power
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.