The Ministry of Health (MoH), via its Chemistry, Food and Drug Division (CFDD) advises of the voluntary recall of the anticoagulant medication, Dabigatran Etexilate, specifically its USP 75 mg and 150 mg Capsules.
Dabigatran Etexilate is used as an oral anticoagulant to lower the risk of stroke and blood clots and produced by Ascend Laboratories LLC.
“While the recalled products are not registered for sale in Trinidad and Tobago, out of an abundance of caution, the Ministry advises persons who may be in possession of the recalled product with the listed lot numbers to discontinue use immediately, and to return the product to the place of purchase where possible,” the Health Ministry stated in its advisory, adding that it will continue to monitor the situation and issue updates as necessary.
According to the Ministry, the recall has become necessary because of the presence of a nitrosamine (N-nitroso-dabigatran), which is above the established Acceptable Daily Intake (ADI) level.
“Nitrosamines are commonly found in water and foods including cured and grilled meats, dairy products and vegetables. However, increased exposure to nitrosamines above acceptable levels, over long periods of time, may be associated with an increased risk of cancer,” the Health Ministry explains.
It added: “To date, Ascend Laboratories LLC., has not received any reports of adverse events related to this recall.”
The Ministry notes additional Information can be obtained by contacting the Office of the Director of the Chemistry, Food and Drugs Division at 623-5242, or by emailing [email protected]