| Subject: | FDA Issues Notice of Recall of Tacrolimus Active Pharmaceutical Ingredient |
| Category: | Food and Drug Administration (FDA)
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| Published: | Tue, 23 May 2006 - 10:00 am |
| Spectrum Laboratory Products and FDA have notified healthcare professionals of the recall of the active pharmaceutical ingredient (API) tacrolimus, an immunosuppressive drug used to prevent rejection of transplanted solid organs such as heart or kidney. Some lots of the ingredient are subpotent and blood levels of tacrolimus in some patients were significantly lower than would be expected based solely on the lower assay results. The use of subpotent tacrolimus in compounded drugs for transplant... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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