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Media Center Overview
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Talecris Biotherapeutics Initiates Voluntary Recall of Plasmanate®
October 13, 2005
Dear Customer:
Because Talecris Biotherapeutics always places patient safety and product integrity as its highest priority, a voluntary recall of one lot of Plasmanate®, Plasma Protein Fraction (Human) 5%, USP has been initiated. The voluntary market recall is being taken as a precautionary measure only, because a portion of the lot was processed during a period of time when the vial oversealer equipment was noted to have fallen out of proper adjustment. If the overseal is not secure, product integrity may not be assured. However, to date, no technical complaints of unsuitable overseals have been received and no adverse clinical events have been reported for this lot.
The recalled lot, #26N39N1 (Material Number 08612407, and NDC Number 0026-0613-25, with an expiration of date of September 20, 2008), was released for distribution on March 17, 2004 with Bayer Biological Products* labeling, and distributed within the United States between March 22, 2004 and November 4, 2004. Talecris has notified the Food and Drug Administration and the PPTA's Patient Notification System of the recall, and is in the process of contacting customers with specific instructions for returning the affected product.
Please examine your inventories of Plasmanate® to determine if you have any stock of this product on hand. If so, please return existing stock of this lot to Talecris at 8368 U.S. 70 West, Clayton, NC 27520. If you have further distributed product from this lot, immediately send notification of this recall to your customers. Talecris will replace returned product free of charge. If you have any technical or clinical questions, please contact U.S. Clinical Communications at (800) 520-2807. If you have inventory that needs replacement, U.S. Customer Service can be contacted at (800) 243-4153.
Talecris Biotherapeutics will continue to make patient safety and product integrity our highest priority. The overseal equipment has already been adjusted to prevent future occurrences. In addition, Talecris will continue to conduct ongoing quality control and quality assurance checks to ensure that all product released to the marketplace meets specifications.
* Talecris Biotherapeutics acquired the contributed assets of the worldwide plasma business of Bayer Biological Products and became operational April 1, 2005. All plasma-based products, related facilities, and employees are now functioning under the name Talecris Biotherapeutics.
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