Safety Alerts & Recalls
What does this mean?
This recall of Thymoglobulin is unlikely to cause any adverse health effects to patients. Healthcare providers have been notified about the recall and will remove the recalled product from their inventory.
If you have received Thymoglobulin and are experiencing side effects or if you have other concerns about your medicine or this recall alert, please follow up with your doctor or other healthcare provider.
Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
Genzyme Recalls Select Lots of Thymoglobulin
Genzyme Corporation has recalled several lots of Thymoglobulin, an anti-rejection drug for kidney-transplant patients, after one lot failed a periodic stability test. This recall includes a number of other lots that are thought to be made with the same raw materials as the lot that failed the stability test.
Genzyme has said no adverse events had been reported and the company has not identified any safety risks to patients from the affected lot.
Thymoglobulin is given to kidney transplant patients to treat acute rejection of the organ, and is given in conjunction with immunosuppression therapy.
The recall affects the following lot numbers: C0062C01, C0072C01, C0086C01, C0094C01, C0096C01, C0098C01, C0098C02, C0098C03, and C0100C01
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