Sagent Pharmaceuticals Issues Recall of Oxacillin for Injection Due to Presence of Iron Oxide Particulate Matter

If injected, the recalled product could pose a serious health risk

Sagent Pharmaceuticals Issues Recall of Oxacillin for Injection Due to Presence of Iron Oxide Particulate Matter
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August 23, 2016

Sagent Pharmaceuticals has announced the voluntary nationwide recall of one lot of Oxacillin for Injection that was manufactured by Astral SteriTech Private Limited and distributed by Sagent.

Sagent has initiated the 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.

The recalled product is packaged in cartons containing 10 x 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.

In the event that 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.

To date, Sagent is not aware of any known adverse patient events resulting from the use of the subject product lot.

Affected consumers 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 Sagentpharma.com.

For additional information on this recall, or questions about returning the recalled product, contact the Customer Call Center at (866) 625-1618.