On May 29, 2024, the U.S. Food and Drug Administration (FDA) announced that Sagent Pharmaceuticals issued voluntary nationwide recall of two lots of docetaxel injection, USP (80 mg per 8 ml multidose vials and 160 mg per 16 ml multidose vials), because of the potential presence of particulate matter from the stopper in the drug product.
“IV administration of an injectable product that contains particulate matter may result in serious adverse events,” Sagent Pharmaceuticals said in the press release FDA shared. “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.”
Sagent Pharmaceuticals said that it has not received any reports of adverse events related to the recall.
The affected product was distributed across the United States from October 11, 2023–April 11, 2024. The following lots, both of which carry a 12/2024 expiration date, are affected:
- Lot number F1030001; NDC 25021-254-16; 160 mg/16 ml
(10 mg/ml) - Lot number F1040001; NDC 25021-254-08; 80 mg/8 ml
(10 mg/ml)
Sagent Pharmaceuticals is notifying customers with a FedEx package that includes arrangements for return of all recalled product. The company is asking customers to:
- Examine their inventory immediately and quarantine, discontinue use or distribution of, and return the recalled lots.
- Identify any customers to whom they may have further distributed the product and notify them of the recall.
- Document the information requested on the recall form.
Customers with questions should contact the customer call center at 866-625-1618, option 1, Monday–Friday from 8 am–5 pm CST. Healthcare workers should contact medical affairs at 866-625-1618, option 3, M-F, Monday–Friday from 8 am–5 pm CST.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product. Healthcare professionals and patients can report any adverse reactions or quality problems experienced with the use of the product to FDA’s MedWatch Adverse Event Reporting program.