On May 28, 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.
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 statement on the FDA’s website. Product was distributed Nationwide from October 11, 2023, to April 11, 2024.
Customers are being notified by a FedEx package that includes arrangements for return of all recalled product. Customers are instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return the recalled lots listed above. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall.
Consumers/distributors/retailers that have product which is being recalled should stop using product and return the recalled product. The necessary form by which to document this information as well as other information regarding this recall is available at www.Sagentpharma.comExternal Link Disclaimer.
