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Trinidad recalls chemotherapy drug over possibility of particulate matter

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Trinidad’s Ministry of Health, through its Chemistry, Food, and Drugs Division, has issued a voluntary recall for two specific batches of Docetaxel Injection, USP, a chemotherapy drug employed in the treatment of various cancers.

The recall involves the 80 mg per 8 mL and 160 mg per 16 mL multi-dose vials.

Potential Risks Identified in Chemotherapy Treatment

The recall was initiated by Sagent Pharmaceuticals, the international distributor, after discovering the potential presence of particulate matter from the stopper in the drug product. 

This could pose significant health risks if administered. Intravenous injection of the affected product could lead to serious complications, including vein inflammation, granuloma formation, and potentially fatal blockages in blood vessels leading to the heart, lungs, or brain.

Safety measures and recommendations

Despite the absence of reported adverse events, the severity and occurrence of potential health issues could vary based on several factors, such as the size and quantity of particulates, along with the patient’s age and overall health. 

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Out of an abundance of caution, the Ministry advises anyone in possession of the recalled products to cease usage immediately. 

They should also return the product to the purchase location, if possible, to ensure safety and prevent any health hazards associated with its use.

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