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Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Microbial Contamination of Non-Sterile Products
Presence of particulate matter: glass
Presence of Particulate Matter; identified as glass
Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Non-Sterility