Oxacillin Lot Recalled Due to Iron Oxide Particulate Matter

Sagent Pharmaceuticals is recalling one lot of injectable oxacillin because a single vial contained dark particulate matter identified as iron oxide.

Sagent Pharmaceuticals is recalling one lot of injectable oxacillin because a single vial contained dark particulate matter identified as iron oxide.

The recalled product is packaged in cartons containing 10 x 10-g pharmacy bulk package bottles identified by NDC 25021-163-99, manufactured by Astral SteriTech Private Limited, and distributed by Sagent. The single lot number being recalled is Lot OXT512, which was distributed to hospitals, wholesalers, and distributors nationwide from June 2016 through July 2016 and expires in March 2017.

Oxacillin is indicated to treat infections cause by penicillinase-producing staphylococci that have shown susceptibility to the drug. If metal particulate is in the product and administered to a patient, it may cause local swelling, irritation of blood vessels or tissue, or blockage of blood vessels—the latter of which can lead to serious and potentially life-threatening adverse effects, such as stroke, heart attack, respiratory failure, kidney failure, or liver failure.

To date, Sagent is not aware of any known adverse events resulting from the use of the recalled product lot. Nevertheless, the company is encouraging its customers to contact their physician or health care provider if they have experienced any problems related to taking or using this product. Adverse reactions or quality problems should also be reported to the FDA’s MedWatch Adverse Event Reporting program.

Sagent is also instructing its customers to examine their inventory immediately and to quarantine, discontinue distribution of, and return any recalled product. Anyone who may have further distributed the product should identify their customers and notify them of this product recall immediately.