SCHAUMBURG, Ill., June 13, 2016 (GLOBE NEWSWIRE) -- Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of one lot of Oxacillin for Injection, USP, 10g (NDC 25021-163-69) Lot OXT515 (Exp. Date July 2017) manufactured by Astral SteriTech Private Limited and distributed by Sagent. Sagent has initiated this voluntary recall of Oxacillin for Injection, USP, 10g to the user level due to the receipt of two product complaints for small, dark particulate matter found in solution after reconstitution. The presence of particulate matter during administration has the potential to cause adverse health consequences in general patient populations.
To date, Sagent is not aware of any known adverse patient events resulting from the use of the subject product lot.
The lot number being recalled is Lot OXT515 which was distributed to hospitals, wholesalers and distributors nationwide from November 2015 through December 2015. Oxacillin for Injection, USP, 10g is indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug. It is available by prescription only.
Customers are being notified by fax, email, FedEx, and/or certified mail that includes arrangements for the return of all recalled product. Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return the recalled lot 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 CDT. Healthcare workers who have medical questions about Oxacillin for Injection, USP may contact Sagent Medical Affairs (866-625-1618, Option 3) M-F 8am-5pm CDT.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
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 leading provider of affordable pharmaceuticals to the hospital market. 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.
INVESTOR CONTACT: Jonathon Singer, Sagent (847) 908-1605 firstname.lastname@example.org CUSTOMER SUPPORT: Customer Call Center (866) 625-1618 SAGENT MEDICAL AFFAIRS (866) 625-1618, Option 3
Source:Sagent Pharmaceuticals, Inc.