Spectrum Laboratory Products, Inc. Issues Nationwide Recall of Tacrolimus Active Pharmaceutical Ingredient

The Food and Drug Administration (FDA) released the following information:

Contact:
Martin LaBenz
(310) 516-8000, Ext. 580

Spectrum Laboratory Products, Inc, (Spectrum), Gardena, California, is initiating a voluntary nationwide recall of the active pharmaceutical ingredient (API) tacrolimus after learning some lots are sub-potent. Tacrolimus is an immunosuppressive drug 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 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. At least one injury has been reported. FDA has been apprised of this action.

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

Spectrum tacrolimus API has been used by pharmacies for compounding purposes. 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.

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.

Spectrum is notifying its distributors and customers by telephone and recall letter and is arranging for return of all recalled products.

Consumers with questions may contact Dawn Salazar at 1-800-791-3210, Ext. 281.

Pharmacies are urged to examine their supplies for any of the recalled tacrolimus API and immediately discontinue its use. Patients and consumers who suspect that they have received medications in any dosage form made from the five lot numbers of tacrolimus that are being recalled should contact their pharmacy or physician. Users should also notify FDA of any complaints or problems associated with these products. Any adverse reactions experienced with the use of this product should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-410, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch