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Recall: Tacrolimus Active Pharmaceutical Ingredient



The immunosuppressive drug Tacrolimus has been voluntarily recalled by Spectrum Laboratory Products, Inc, (Spectrum), in Gardena, California. Some of the lots were found to be sub-potent after some patients' blood levels of the active pharmaceutical ingredient (API) Tacrolimus were substantially lower than would be expected.

Transplant patients using sub-potent Tacrolimus in compounded drugs risk sub-therapeutic Tacrolimus blood levels and could potentially reject organ transplants.

Recalled Tacrolimus lots include: TA1210, UD1060, UF0298, UL0964, VB0031. Tacrolimus API was distributed to pharmacies, one university (1 bottle), and one pharmacy distributor (2 bottles) for use in compounding. It can be identified by catalog number T3192 and the name "Tacrolimus" on the label.

Pharmacies are notified to discontinue using recalled Spectrum Tacrolimus (API) for compounding purposes. Patients should not discontinue the drug but are advised to contact their physician or pharmacist immediately.

Contact Spectrum at 1-800-791-3210, Ext. 281. Any adverse reactions from this product should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088.

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