Media Release - Voluntary recall of oral anticoagulant - Dabigatran Etexilate Capsules by Ascend Laboratories LLC

Port of Spain, March 29, 2023: The Ministry of Health (MoH), via its Chemistry, Food and Drug Division (CFDD) advises of the voluntary recall of Dabigatran Etexilate Capsules. USP 75 mg and 150 mg due to the presence of a nitrosamine (N-nitroso-dabigatran), which is above the established Acceptable Daily Intake (ADI) level. The product is used as an oral anticoagulant to lower the risk of stroke and blood clots.

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. To date, Ascend Laboratories LLC., has not received any reports of adverse events related to this recall.

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 (see tables below) , to discontinue use immediately and to return the product to the place of purchase where possible.

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 cfdd@health.gov.tt.

The Ministry of Health will continue to monitor the situation and advise the population as necessary.