Categories
Resources
Your Recalls
Loading...
Get email alerts when new recalls match your interests.
Lack of Assurance of Sterility
Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Superpotent Drug
Failed Impurities/Degradation Specifications - at 18-month Stability testing
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Failed Dissolution Specifications: below specification results
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Presence of Particulate Matter
Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.