The United States: The United States: Sagent Pharmaceuticals initiates a nationwide voluntary recall of Oxacillin for Injection, USP, 10g due to presence of Iron Oxide particulate matter (English Only)

The United States: The United States: Sagent Pharmaceuticals initiates a nationwide voluntary recall of Oxacillin for Injection, USP, 10g due to presence of Iron Oxide particulate matter (English Only)
 
Sagent Pharmaceuticals, Inc. announced 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 has initiated this voluntary 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. 

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. 

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 which was distributed to hospitals, wholesalers and distributors nationwide from June 2016 through July 2016. 

Please refer to the following website in FDA for details: http://www.fda.gov/Safety/Recalls/ucm517328.htm 

In Hong Kong, the above product is not a registered pharmaceutical product. 

Ends/ Saturday, August 20, 2016 
Issued at HKT 13:45 

 

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