Sagent Pharmaceuticals, Inc. Initiates A Nationwide Voluntary Recall Of Two Lots Of Zoledronic Acid Injection, 5mg/100ml Due To Potential Lack Of Container Integrity
3/5/2014 6:43:29 AM
Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of Two Lots of Zoledronic Acid Injection, 5mg/100mL due to Potential Lack of Container Integrity
SCHAUMBURG, Ill., March 4, 2014 (GLOBE NEWSWIRE) -- Sagent Pharmaceuticals, Inc. (SGNT) today 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. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. The necessary form by which to document this information as well as other information regarding this recall is available at www.Sagentpharma.com.
Any questions about returning unused product should be directed to the customer call center at (866) 625-1618 M-F 8am-7pm CST. Healthcare workers who have medical questions about Zoledronic Acid Injection may contact Sagent Medical Affairs (866-625-1618, Option 3) M-F 8am-5pm CST.
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.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
About Sagent Pharmaceuticals, Inc.
Sagent Pharmaceuticals, Inc., founded in 2006, is a specialty pharmaceutical company focused on developing, manufacturing, sourcing and marketing pharmaceutical products, with a specific emphasis on injectables. Sagent has created a unique global network of resources, comprising rapid development capabilities, sophisticated manufacturing and innovative drug delivery technologies, resulting in an extensive and rapidly expanding pharmaceutical product portfolio that fulfills the evolving needs of patients.
Customer Call Center
SAGENT MEDICAL AFFAIRS
(866) 625-1618, Option 3
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