Class I - Dangerous
Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
Morton Grove Pharmaceuticals
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14
Defective Container: Tamper Evident foil seal not completely intact.
Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product.
Class I - Dangerous
Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.