Sagent Pharmaceuticals has 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 (4) 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.