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Product Recalls and Withdrawals
Manufactured products by nearly every segment of industry have been subject to recalls or withdrawals, and consumer medicine and medical products are not exempt. A product recall or withdrawal is a request or warning to stop using a product usually due to the discovery of safety issues, and sometimes, return the product to the maker, Products used by individuals in the treatment of primary immunodeficiency diseases, which includes users of blood and blood products, vaccines, allergenics, and biological therapeutics, are occasionally subject to product recalls.
To make it easy to track the use of medical products, it is imperative that patients record both the name and the lot number of any products they may be using in case such a recall occurs.
Patient Notification System
The Patient Notification System is a free, confidential, 24-hour communication system designed to provide plasma product consumers, health care professionals, and patient family members with timely, automatic updates about plasma product withdrawals and recalls from all participating manufacturers. Led by the Plasma Protein Therapeutics Association (PPTA), the Patient Notification System was developed by the producers and distributors of plasma products in direct response to consumer requests.
The Immune Deficiency Foundation was instrumental in the development of the Patient Notification System and encourages patients and professionals to enroll in the program.
To access the Patient Notification System, call 1-888-UPDATE-U (1-888-873-2838) or register online at www.patientnotificationsystem.org. Once you are registered, you will automatically be notified of any product recalls or withdrawals via telephone, fax, e-mail or overnight letter, depending on your indicated preference.
FDA’s Center for Biologics Evaluation and Research
The United States Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) holds the authority to regulate biological products and ensure their safety for the American public. To learn more about biological products, including IVIG, in the United States, please visit CBER’s Web site.
Please use the link below for information regarding recent recalls or withdrawals of Immune Globulin from the U.S. market.
http://www.fda.gov/cber/health.htm
The following link is the home page for all blood information. This FDA page also has links for applicable advisory committees (BPAC, TSEAC, HHS ACBSA), product shortage information and safety information.
