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The firms own SOP states that OOS results must be immediately reported to Quality and the pharmacist-in-charge, and that investigation, root cause analysis, recall, and customer notification procedures shall be followed when applicable. The FDA pointedly notes that the when applicable language effectively makes investigation and notification optional rather than mandatory
Symptomatic Patients: For a patient with Pernicious Anemia, a single day without the injection can be significant
Notes: Requires reconstitution with bacteriostatic water
The PRIDE database at 20 years: 2025 update
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