Port of Spain, August 09, 2024: The Ministry of Health (MoH), via its Chemistry, Food and Drugs Division advises of the voluntary recall of one lot of Heparin Sodium in 0.9% Sodium Chloride Injection to the consumer level. The recall was issued by Baxter International Inc. due to the potential for elevated endotoxin levels based on issues related to the bacterial endotoxin test specific to lot number N008235.
Heparin Sodium in Sodium Chloride Injection is indicated as an anticoagulant to maintain catheter patency and is packaged in 2,000 USP units, 1,000 mL in VIAFLEX Plus Plastic Container -1 unit per pouch. Use of heparin with higher than acceptable endotoxin levels may lead to significant adverse health consequences ranging from febrile reactions to toxic shock, multi-organ failure and death. This issue affects one lot of product code that was distributed between March 12, 2023 and August 24, 2023, to healthcare facilities, wholesalers and distributors in the United States. The product code and lot number can be found on the individual product and shipping carton. See the product image below for more on where this information can be found.
While the recalled products are not registered for use in Trinidad and Tobago, out of an abundance of caution, the Ministry advises persons who may be in possession of these recalled products 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 via email at cfdd@health.gov.tt or phone at 217-4664 ext. 13101.
The Ministry of Health will continue to monitor the situation and advise the population as necessary.
