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Whether you are a 503A pharmacy compounder or a 503B Outsourcing Facility you should have your labeling, Website and Social Media advertising, P&P and compounded products reviewed for compliance with current FDA Guidance

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If the injection is needed (e.g., to replete B or B in a deficient mother), it can be used, but the infant should be observed for any unusual symptoms (though none would be expected from B vitamins, apart from perhaps looser stools if anything)

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If you have any questions about the use of Hydroxocobalamin 20 mg/ml Injection Solution, please reach out to us