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| The United States: Sagent Pharmaceuticals issues voluntary nationwide recall of Docetaxel Injection, USP due to potential presence of particulate matter (English Only) |
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The US Food and Drug Administration (FDA) announces that Sagent Pharmaceuticals announced the voluntary nationwide recall of the following products 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. The product was distributed by Sagent Pharmaceuticals. The affected products are:
- Docetaxel Injection, USP, 160mg/16ml (lot number: F1030001)
- Docetaxel Injection, USP, 80mg/8ml (lot number: F1040001)
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.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sagent-pharmaceuticals-issues-voluntary-nationwide-recall-docetaxel-injection-usp-due-potential
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Thursday, May 30, 2024
Issued at HKT 16:00
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