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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

In its 348th meeting, the Registration Board decided that the Mecobalamin / Methylcobalamin Tablet monograph will now follow the Japanese Pharmacopoeia (JP) standards

(PubMed) Kalantari P, Narayan V, Natarajan SK, et al