MoH advises of voluntary recall of chemotherapy drug

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MoH advises of voluntary recall of chemotherapy drug

The Health Ministry’s Chemistry, Food and Drugs Division has advised of the voluntary recall of two lots of Docetaxel Injection, USP.

The affected products are the 80 mg per 8 mL multi-dose vials and 160 mg per 16 mL multi-dose vials.

Sagent Pharmaceuticals, the international distributor, issued the recall over a potential presence of particulate matter from the stopper in the drug product.

The medicine is a chemotherapy drug and it’s used to treat many types of cancers like breast cancer, certain stomach cancers, head and neck cancer, lung cancer, and prostate cancer.

The label and affected lot numbers with Expiration Dates and NDC number can be found in the table below.

The recall followed a customer complaint due to the potential presence of particulate matter from the stopper in the drug product.

Sagent said 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 company said 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, the pharmaceutical company has not received any reports of adverse events related to the recall.

The recalled products aren’t registered for local use but, out of an abundance of caution, the Ministry advised those who may be in possession of the recalled products to discontinue use immediately and to return the product where they bought it, if possible.

Contact the Office of the Director of the Chemistry, Food and Drugs Division via email at [email protected] or phone at 217-4664 ext. 13101 for additional information.