Sagent Pharmaceuticals recalls Oxacillin for injection
SCHAUMBURG - Sagent Pharmaceuticals announced the voluntary nationwide recall of one lot of Oxacillin for Injection, manufactured by Astral SteriTech Private Limited and distributed by Sagent.
Sagent initiated the voluntary recall 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.
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 8 a.m.-7 p.m. CDT. Health care workers who have medical questions about Oxacillin for Injection, USP may contact Sagent Medical Affairs (866-625-1618, Option 3) M-F 8 a.m.-5 p.m. CDT.
Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using the product.