August 22, 2016
Sagent Pharmaceuticals announced the recall of oxacillin for injection, USP, 10 g. The company received a complaint about the presence of dark particulate matter, later identified as iron oxide.
The products were manufactured by Astral SteriTech Private Limited. The impacted lot is #OXT512, with an expiration of March 2017 (NDC 25021-163-99).
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Administration of a product with a metal particulate can cause a number of adverse events, including life-threatening blockage of the blood vessels, the company noted. However, no adverse events have been reported.
Earlier this month, Sagent launched a recall of this same medication due to complaints of the presence of dark particulate matter, according to the US Food and Drug Administration. The impacted lot in that recall was #OXT515, with an expiration of July 2017.
For more information and questions, the company can be reached at (866) 625-1618.
Sagent Pharmaceuticals. Sagent Pharmaceuticals initiates a nationwide voluntary recall of oxacillin for injection, USP, 10 g due to presence of iron oxide particulate matter [press release]. www.fda.gov. August 18, 2016.