Recall Issued for Injectable Antibiotic

The recalled lot was found to contain a particulate matter after reconstitution
The recalled lot was found to contain a particulate matter after reconstitution

Sagent announced a voluntary recall of one lot of Oxacillin for Injection, 10g due to a complaint of a small, dark particulate matter found within the solution after reconstitution.

Oxacillin for Injection, a penicillinase-resistant penicillin, is an antibiotic indicated for the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug. 

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The particulate matter has been confirmed to be iron oxide. If the metal particulate in an injectable drug is administered to a patient, it can lead to local swelling, irritation of blood vessels or tissue, or blockage of blood vessels. Moreover, blockage of blood vessels can lead to serious events, such as stroke, heart attack, respiratory failure, kidney failure, or liver failure. 

The affected product, which has Lot #OXT512 and an expiration date of March 2017, was packaged in cartons containing 10x10g pharmacy bulk package bottles.  It was manufactured by Astral SteriTech Private Limited and distributed by Sagent between June–July 2016. 

Customers in possession of the recalled product are to quarantine, discontinue distribution, and return the lot of product. Currently, Sagent is not aware of any known adverse events due to use of the recalled product lot.

For more information call (866) 625-1618 or visit SagentPharma.com.

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