Sagent Voluntarily Recalls One Lot of OxacillinBy
Sagent Pharmaceuticals has announced the voluntary nationwide recall of one lot of oxacillin for injection, USP, 10 g, manufactured by Astral SteriTech Private Limited and distributed by Sagent. Sagent has initiated this voluntary recall 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, 10 g 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.
Source: Sagent Pharmaceuticals