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The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared YELLOW #6 AND RED #40.
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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.