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Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
FDA analysis of the product found that the product consisted of mainly sodium nitrite. The product's label failed to bear adequate directions for use as required in 21 CFR 172.175. Failure to provide these directions for use may result in overuse that can pose an life-threatening hazard to health.