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March 4, 2014
12:06 EDTSGNTSagent Pharmaceuticals initiates voluntary recall of Zoledronic Acid lots
Sagent Pharmaceuticals announced the voluntary nationwide recall of two lots of Zoledronic Acid Injection, 5mg/100mL premix bag (NDC number 25021-830-82) distributed by Sagent. Sagent has initiated this voluntary recall of Zoledronic Acid Injection, 5mg/100mL to the user level due to the discovery of four leaking premix bags detected during an investigation conducted in response to a product complaint. The subject bags were not administered to patients as the leakage was readily apparent. A non-integral premix bag can result in a lack of sterility assurance. Sagent is not aware of any adverse patient events resulting from the use of this product and is continuing its investigation of the situation. The lots being recalled are numbers 30076 and 30077 which were distributed to hospitals, wholesalers and distributors nationwide from October 9, 2013 through February 18, 2014. Zoledronic Acid Injection, 5mg/100mL is a bisphosphonate indicated for the treatment of Paget's disease of bone in men and women and is supplied in a premix bag. Sagent's distributor DDN (DOHMEN Life Science Services) is notifying Sagent's distributors and customers by fax, email and certified mail and is arranging for return of all recalled product.Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return the recalled lots of product. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall.
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February 23, 2015
11:20 EDTSGNTSagent Pharmaceuticals initiates voluntary recall of Atracurium Besylate
Sagent Pharmaceuticals announced the voluntary nationwide recall of two lots of Atracurium Besylate Injection, USP, 50mg/5mL single-dose vials and four lots of Atracurium Besylate Injection, USP, 100mg/10mL multi-dose vials manufactured by Emcure Pharmaceuticals Ltd. and distributed by Sagent. Sagent has initiated this voluntary recall of Atracurium Besylate Injection, USP, 50mg/5mL and 100mg/10mL to the user level due to FDA observations pertaining to aseptic and GMP practices at the manufacturer's site potentially impacting product sterility. Non-sterility of a drug administered via the intravenous route has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised. Sagent has transferred the manufacture of this product to its own facility and this product manufactured at the Sagent facility will not be impacted by the recall. Sagent is not aware of any adverse patient events resulting from the use of the subject product lots. The lot numbers being recalled are VATA012, VATA015 and VATB012, VATB013, VATB014, VATB017 which were distributed to hospitals, wholesalers and distributors nationwide from February 2014 through February 2015. Atracurium Besylate Injection, USP, 50mg/5mL and 100mg/10mL is indicated, as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation, and is supplied in single-dose and multi-dose vials.

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