Centurion Medical Products Corporation, of Williamston, Michigan, just recalled some of its customized convenience kits that contain <"http://www.yourlawyer.com/practice_areas/defective_drugs">Bacteriostatic Sodium Chloride Injection, USP, 0.9% 30 mL, the U.S. Food and Drug Administration (FDA) just announced. The Multiple Dose Vials were manufactured by Luitpold Pharmaceuticals, Inc., and distributed by American Regent, Inc.
The Convenience Kit recall was implemented in response to American Regentâ€™s recall of three lots of vials because some may contain visible particulates. We have previously reported on the American Regent recall.
The recalled American Regent products were included in customized convenience kits manufactured by Centurion Medical Products to 106 health care facilities in the United States.
Centurion has ceased including the defective American Regent products in its kits. The other components included in the kits are not affected by the recalled American Regent product. The kits are customized for specific health care facilities and Centurion notified these customers and distributors by certified letter on March 31, 2011.
Bacteriostatic Sodium Chloride Injection, USP, 0.9% is used for preparing and diluting sterile solutions. To date, Centurion has not received any reports of adverse reactions from the use of this product. A complete list of the recalled products can be accessed here.
Customers with any of the affected products should not use them. Continued use of the affected lots of Bacteriostatic Sodium Chloride Injection products from American Regent, Inc. may result in potential adverse events such as disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness due to accumulation of inflammatory cells), and granuloma formation.
Centurionâ€™s Recall Coordinator can be reached, toll-free, at 1.800.248.4058, extension 1156, Monday through Friday, from 7:00 a.m. through 3:30 p.m., Eastern Time. To return the recalled product and receive credit or replacement product, customers are directed to contact Centurionâ€™s Recall Coordinator, as specified in the notices that have been distributed.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax: Online: www.fda.gov/medwatch/report.htm; Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at:â€¨www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form; and by Fax: 1-800-FDA-0178.