Prescription and over-the-counter medications
Advanced Accelerator Applications USA
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
CGMP Deviations: Presence of NDMA impurity detected in product.
Preferred Pharmaceuticals
CGMP Deviations: Presence of NDMA impurity detected in product.
Preferred Pharmaceuticals
CGMP Deviations: Presence of NDMA impurity detected in product.
Assurance Infusion
Lack of sterility assurance.
Lack of sterility assurance.
Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
Microbial contamination of non-sterile product.
Lack of sterility assurance.
Assurance Infusion
Lack of sterility assurance.
Assurance Infusion
Lack of sterility assurance.
Assurance Infusion
Lack of sterility assurance.
Assurance Infusion
Lack of sterility assurance.
Assurance Infusion
Lack of sterility assurance.
Assurance Infusion
Lack of sterility assurance.
Assurance Infusion
Lack of sterility assurance.
Assurance Infusion
Lack of sterility assurance.
Assurance Infusion
Lack of sterility assurance.
Assurance Infusion
Lack of sterility assurance.
Sun Pharmaceutical Industries
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.