Recall: tacrolimus for compounding

May 22, 2006 - Spectrum Laboratory Products and the 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 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. 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.

Tacrolimus is identified as Catalog Number T3192. Recalled lots include the following: TA1210, UD1060, UF0298, UL0964, VB0031.

Pharmacies that have used the Spectrum tacrolimus API that is being recalled should stop using it and contact Spectrum to make arrangements to return it. 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.

Patients receiving compounded tacrolimus for solid organ transplant should not stop taking their medication, but rather should check with their physician or pharmacist.

Consumers who have purchased compounded tacrolimus should contact Dawn Salazar at 1-800-791-3210, Ext. 281. As always, pharmacies and members can also contact the RxAmerica customer service desk at 1-800-770-8014 if they have any questions about this new product recall.