The Ministry of Health (MoH), via its Chemistry, Food and Drug Division (CFDD) advises of the voluntary recall of Digoxin Tablets USP, 0.125mg and one lot of Digoxin Tablets USP, 0.25mg.
The recall issued by Marlex Pharmaceuticals Incorporated, the manufacturer of the product, is as a result of a label mix-up.
Bottles of Digoxin Tablets, USP 0.125mg were incorrectly labelled and contain Digoxin Tablets USP, 0.25mg. Bottles of Digoxin Tablets USP, 0.25mg were incorrectly labelled and contain Digoxin Tablets USP, 0.125mg.
The product is used for the treatment of mild to moderate heart failure.
This can cause either overdosing or underdosing in patients who unknowingly take this incorrectly labelled product.
Marlex Pharmaceuticals Incorporated has not received any reports of adverse events related to this recall.
Marlex Pharmaceuticals Incorporated has identified the following lots for recall:
Product Name Strength Drug Code Lot Expiry Date
Digoxin 0.125mg 10135-0747-01 E3810 February 2025
Digoxin 0.25mg 10135-0748-01 E3811 February 2025
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 and expiration dates, to discontinue use immediately and to return the product to the pharmacy unit of the nearest Public Health Facility.
Additional Information can be obtained by contacting the Office of the Director of the Chemistry, Food and Drugs Division at [email protected] or via telephone at 623-5242 or 226-8236.
The Ministry of Health will continue to monitor the situation and advise the population as necessary.