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Safety, Regulation, and Quality Concerns From a regulatory perspective, AOD 9604 is not approved by the US FDA, and thus it has no approved medical indications

When B12 levels are low, red blood cells can become large and inefficient, contributing to fatigue and weakness
Pyridoxine is categorized as pregnancy category A, meaning controlled studies have shown no risk to the fetus

It also influences gene expression patterns that control whether cells store or burn fat

Topical: mild irritation , redness or dryness
