Sagent Pharmaceuticals Issues Nationwide Recall

On August 18, 2016, Sagent Pharmaceuticals voluntarily recalled one lot of Oxacillin for Injection, USP, 10 g nationwide due to particulate matter. The recall was in response to a complaint about a single vial containing small, dark particulate matter. The particulate was found in the solution after reconstitution and has been identified iron oxide. Sagent has not received notice of any adverse events associated with the lot.

The recalled product was manufactured by Astral SteriTech Private Limited and distributed by Sagent nationwide from June–July 2016. The 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 (Exp. Date March 2017).

According to Sagent, Oxacillin for Injection, USP, 10 g is available by prescription only for the treatment of infections caused by penicillinase producing staphylococci that have demonstrated susceptibility to the drug. A metal particulate in an injectable product may result in local swelling, irritation of blood vessels or tissue, or blockage of blood vessels.

Sagent is advising customers to quarantine and discontinue distribution of the product. Adverse events may be reported to FDA.

Source: FDA