FDA MedWatch – Docetaxel Injection USP, by Sagent Pharmaceuticals

TOPIC: Docetaxel Injection USP, by Sagent Pharmaceuticals: Recall – Due to Potential Presence of Particulate Matter

AUDIENCE: Patient, Health Professional, Oncology, Pharmacy

ISSUE: Sagent Pharmaceuticals is recalling two lots of Docetaxel Injection USP, (80 mg per 8 mL multi-dose vials and 160 mg per 16 mL multi-dose vials) 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.

For more information about this recall, click on the red button “Read Recall“ below.

BACKGROUND: Docetaxel injection is used alone or in combination with other medications to treat certain types of breast, lung, prostate, stomach, and head and neck cancers. Docetaxel injection is in a class of medications called taxanes. It works by stopping the growth and spread of cancer cells.

RECOMMENDATIONS: 

• Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

• Customers with any questions about returning unused product are directed to the customer call center at (866) 625-1618. Healthcare workers who have medical questions about Docetaxel Injection, USP may contact Medical Affairs (866) 625-1618, Option 3. 

• Customers are instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return the recalled lots.

• 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 the product which is being recalled should stop using the 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.com.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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