Categories
Resources
Your Recalls
Loading...
Get email alerts when new recalls match your interests.
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.
CGMP Deviations: sterile water not used for production
Failed Dissolution Specifications: below specification results
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Undeclared cashews. The firm was notified by a customer that the top label and the carton labels do not match. The carton label states, "coconut milk" while the top label states, "cashew milk". The product actually contains the cashew milk product.
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.
CGMP Deviations
Potential foreign material - plastic
Defective container; yellow colored spike from cap lodged in the nozzle
Undeclared Fish Allergen
Subpotent Drug: reduced efficacy for epinephrine
CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.