Categories
Resources
Your Recalls
Loading...
Get email alerts when new recalls match your interests.
Undeclared allergen (milk)
Subpotent Drug
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
CGMP Deviations
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Lack of Assurance of Sterility: leaking bags
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Lack of Assurance of Sterility
Lack of Assurance of Sterility: Firm did not perform process validation.