Safety Report: Sagent Docetaxel Injection, USP - recalled due to presence of particulate matter, USA

United States

Sagent Pharmaceuticals today announced the voluntary recall of two lots of Docetaxel Injection, USP to the User Level as the result of a customer complaint due to the potential presence of particulate matter from the stopper in the drug product. The product was distributed by Sagent Pharmaceuticals nationwide from October 11, 2023, to April 11, 2024. .

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.

The Docetaxel Injection, USP, label and affected lot numbers with Expiration Dates and NDC number can be found below:
- Product: DOCETAXEL INJECTION, USP, Lot Number: F1030001, NDC: 25021-254-16, Expiration Date: 12/2024, Strength: 160 mg/16 mL (10 mg/mL).
- Product: DOCETAXEL INJECTION, USP, Lot Number: F1040001, NDC: 25021-254-08, Expiration Date: 12/2024, Strength: 80 mg/8 mL (10 mg/mL).

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.

In case you experienced harm from extraneous materials, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Sagent Pharmaceuticals
Brand name: Sagent
Product recalled: Docetaxel Injection, USP
Reason of the recall: Potential presence of particulate matter
FDA Recall date: May 29, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sagent-pharmaceuticals-issues-voluntary-nationwide-recall-docetaxel-injection-usp-due-potential