ACTION OF TACROLIMUS

Spectrum Laboratory Products, Inc. Issues Nationwide Recall of Tacrolimus Active Pharmaceutical IngredientFDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. Blood levels of tacrolimus in some patients were significantly lower than would be expected based solely on the lower assay results. The use of sub-potent tacrolimus in compounded drugs for transplant recipients may lead to sub-therapeutic tacrolimus blood levels and an unacceptably increased risk of solid organ transplant rejection. At least one injury has been reported. FDA has been apprised of this action.