Sagent Vecuronium Bromide Recall Issued Due to Impurities
Three lots of vecuronium bromide injections, which are used as muscle relaxants, have been recalled due to the discovery of a high impurity rate in the solution during routine quality testing, posing increased health risks for critically ill users with renal failure.
A Sagent pharmaceuticals vecuronium bromide injection recall was announced by the FDA on June 7, after elevated levels of impurities were found within 10 mg vials of the solution during random quality samples at the 18 month interval. No adverse health consequences have been reported to date in relation with the injection solution.
Vecuronium Bromide injections are used as an alternative to anesthesia for surgery and acts as a paralyzing agent and muscle relaxer to ensure the patient’s safety during surgery.
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The recall consists of Vecuronium Bromide injection, 10 mg manufactured by Mustafa Nevzat with lot numbers 11I30481A, 11I30721A, or 11I32581A and NDC number 25021-657-10.
The product was manufactured by Mustafa Nevzat Ilac Sanayii A.S. who is part of MN Pharmaceuticals, and was distributed by Sagent to hospitals, wholesalers, and distributors nationwide from January 2012 through May 2012.
Sagent’s distributor DDN has begun notifying Sagent’s distributors and customers by fax, email, and certified mail and is instructing customers to examine their inventory for recalled lot numbers and NDC numbers and to immediately quarantine, discontinue distribution, and to return all recalled lots of the product. Customers may contact 866-625-1618 or visit the website www.sagentpharma.com to learn more about to return process.
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