Spectrum Recalls Tacrolimus

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ePT--the Electronic Newsletter of Pharmaceutical Technology

Spectrum Laboratory Products (Gardena, CA) recalled its active pharmaceutical ingredient, tacrolimus, after learning that some lots of the ingredient are subpotent. At least one injury has been reported.

Spectrum Laboratory Products (Gardena, CA, www.spectrumchemical.com)recalled its active pharmaceutical ingredient (API), tacrolimus,after learning that some lots of the ingredient are subpotent. At leastone injury has been reported. Spectrum informed the US Food andDrug Administration (FDA, Rockville, MD, www.fda.gov) of the recall.

Tacrolimus is an immunosuppressive drug used to prevent the rejectionof transplanted solid organs such as hearts or kidneys. Pharmacies haveused the ingredient for compounding purposes. Subpotent tacrolimus incompounded drugs for transplant recipients may result in subtherapeutictacrolimus blood levels and an unacceptable increased risk ofsolid-organ transplant rejection.

Tacrolimus is identified as catalog number T3192. Recalled lots includeTA1210, UD1060, UF0298, UL0964, and VB0031. The recall does not applyto tacrolimus marketed in finished dosage form as "Prograf" or toPrograf oral capsules, which are sometimes used for compounding.Patients receiving tacrolimus for solid-organ transplants should notstop taking their medication, but should consult their physicians orpharmacists. Pharmacies should stop using tacrolimus and contactSpectrum to make arrangements to return it.