Sagent Pharmaceuticals initiates voluntary recall of zoledronic acid injection

The company has announced this voluntary recall to the user level following the discovery of four leaking premix bags during an investigation conducted in response to a product complaint. This recall is being conducted with the knowledge of the US Food and Drug Administration.

As the leakage was readily apparent, the subject bags were not administered to patients. A non-integral premix bag can result in a lack of sterility assurance.

The company is recalling lots with numbers 30076 and 30077. The lots were distributed to hospitals, wholesalers and distributors nationwide from 9 October 2013 through 18 February 2014.

Dohmen Life Science Services, the distributor of Sagent Pharmaceuticals, is notifying Sagent’s distributors and customers about the recall and is arranging for return of all recalled product.

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.