Antibiotic Recall; Iron Oxide Particulates; Vial with Possible Rust

Sagent Pharmaceuticals, Inc. announced on August 19, 2016 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. Sagent initiated this recall to the user level due to the receipt of a product complaint for a single vial containing small, dark particulate matter found within the solution after reconstitution. The particulate matter has been identified as iron oxide.


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.


If metal particulate in an injectable product is administered to a patient, it may result in local swelling, irritation of blood vessels or tissue, or blockage of blood vessels. Blockage of blood vessels can lead to serious events, which may be life-threatening, such as stroke, heart attack, respiratory failure, kidney failure, or liver failure.


The product is packaged in cartons containing 10 10-gram Pharmacy Bulk Package bottles identified by NDC 25021-163-99. The lot number being recalled is Lot OXT512 which was distributed to hospitals, wholesalers and distributors nationwide from June 2016 through July 2016.


See the FDA Safety Alert


See the FDA Recall


See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication