Company issues nationwide recall of drug used in transplantpatients

June 1, 2006

Spectrum Laboratory Products, Inc., is initiating a voluntarynationwide recall of the active pharmaceutical ingredienttacrolimus after learning some lots are sub-potent.

Spectrum Laboratory Products, Inc., is initiating a voluntary nationwide recall of the active pharmaceutical ingredient tacrolimus after learning some lots are sub-potent. Tacrolimus, an immunosuppressive drug, is used to prevent rejection of transplanted solid organs such as heart or kidney. Blood levels of tacrolimus in some patients were significantly lower than would be expected based solely on the lower assay results, the FDA reported.

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.

The recall does not apply to tacrolimus marketed in finished dosage form as Prograf or as Prograf oral capsules that have been used for compounding.