Sagent Pharmaceuticals announced the voluntary nationwide recall of two lots of Docetaxel Injection, USP (80 mg per 8 mL multi-dose vials and 160 mg per 16 mL multi-dose vials). The product was distributed by Sagent Pharmaceuticals. Sagent has initiated this voluntary recall of Docetaxel Injection, USP to the User Level as the result of a customer complaint due to potential presence of particulate matter from the stopper in the drug product.
Risk Statement: Intravenous administration of an injectable product that contains particulate matter may result in serious adverse events. Potential complications related to injection of particles include 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 frequency and severity of these adverse events could vary depending upon a variety of factors including the size and number of particles in the drug product, patient comorbidities (such as age, compromised organ function), and presence or absence of vascular anomalies.
To date, Sagent Pharmaceuticals has not received any reports of adverse events related to this recall.
The Docetaxel Injection, USP, label and affected lot numbers with Expiration Dates and NDC number can be found in the table below. Product was distributed Nationwide from October 11, 2023, to April 11, 2024.
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