Sagent Pharma Recalls Chemotherapy Drug Docetaxel Injection

(RTTNews) - Sagent Pharmaceuticals has recalled two lots of chemotherapy drug Docetaxel Injection, USP due to potential presence of particulate matter from the stopper in the drug, according to the U.S. Food and Drug Administration.

The 160 mg/16 mL Docetaxel Injection comes with lot number F1030001, NDC 25021-254-16 and expiration date of 12/2024. The 80 mg/8 mL product comes with lot number F1040001, NDC 25021-254-08 and expiration date of 12/2024.

The product was distributed by Sagent nationwide from October 11, 2023 to April 11, 2024.

According to the agency, intravenous administration of an injectable product that contains particulate matter may result in serious adverse events, including inflammation of a vein, granuloma, and blockage of blood vessels in the heart, lungs or brain which can cause stroke or life-threatening blood clot events.

The 80 mg per 8 mL multi-dose vials and 160 mg per 16 mL multi-dose vials were called back following customer complaint. However, Sagent has not received any reports of adverse events related to the recalled drug so far.

Customers are asked to quarantine, discontinue distribution of and return the recalled lots. They are being notified by a FedEx package that includes arrangements for return of all recalled product.

In similar recalls, Hospira, Inc., affiliated to dug major Pfizer Inc., last week called back select lots of Buprenorphine Hydrochloride Injection Carpuject Units and Labetalol Hydrochloride Injection Carpuject Units due to the potential for incomplete crimp seals.

For More Such Health News, visit rttnews.com https://www.rttnews.com/content/health.aspx

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