Tacrolimus Active Pharmaceutical Ingredient [API]

May 18, 2006

Audience: Pharmacists and organ transplantation healthcare professionals

[Posted 05/18/2006] Spectrum Laboratory Products and FDA notified healthcare professionals of the recall of the active pharmaceutical ingredient tacrolimus, an immunosuppressive drug used to prevent rejections of transplanted solid organs such as heart or kidney, after learning that some lots of the ingredient are subpotent. Spectrum's tacrolimus API has been used by pharmacies for compounding purposes. The use of sub-potent tacrolimus in compounded drugs for transplant recipients may lead to sub-therapeutic tacrolimus blood levels and an unacceptable increased risk of solid organ transplant rejection. Patients receiving tacrolimus for solid organ transplant should not stop taking their medication, but rather should check with their physician or pharmacist. This recall does not apply to tacrolimus marketed in finished dosage form as Prograf (Astellas Pharma, US) or to Prograf oral capsules that have been used for compounding.

[May 11, 2006 - Press Release - Spectrum Laboratory Products]

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