PORT OF SPAIN, Trinidad – The Ministry of Health Tuesday announced a voluntary recall of the Vancomycin Hydrochloride for Oral Solution, warning that patients could be at risk of cardiac arrest.
It said that the drug is administered for the treatment of enterocolitis caused by Staphylococcus aureus and that the recall was issued by Amneal Pharmaceuticals, LLC due to the potential overfilling of bottles.
“Due to the potential overfilling of these bottles, patients who are prescribed the maximum daily dose of up to two grams per day of Vancomycin Hydrochloride for oral solution, USP 250 mg/5mL, may receive up to four grams of oral vancomycin per day.
“Patients with compromised intestinal/stomach and renal function may be at risk for electrolyte abnormalities such as high potassium which may lead to cardiac arrest,” the ministry said.
The health authorities said that 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 these recalled products to discontinue use immediately and to return the product to the place of purchase where possible”.
The ministry said that it will continue to monitor the situation and advise the population as necessary.