FDA: Sagent Pharmaceuticals recalls one lot of Oxacillin for Injection

Editor's Note

The Food and Drug Administration (FDA) on August 19 announced the recall by Sagent Pharmaceuticals, Inc (Schaumburg, Illinois), of one lot of Oxacillin for Injection, USP, 10 g (NDC 25021-163-99) Lot OXT512 (Exp Date March 2017).

The recall was initiated because of a user complaint of a vial containing small, dark particulate matter in the solution after reconstitution. The particulate matter was identified as iron oxide.

Administering an injectable product with metal particulate can result in blockage of blood vessels, which can lead to stroke, heart attack, respiratory failure, kidney failure, or liver failure.

Posted 08/19/2016] AUDIENCE: Pharmacy ISSUE: Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of one lot of Oxacillin for Injection, USP, 10 g (NDC 25021-163-99) Lot OXT512 (Exp. Date March 2017) manufactured by Astral SteriTech Private Limited and distributed by Sagent.