The Ministry of Health is informing the public of the voluntary recall of Vancomycin Hydrochloride for Oral Solution USP (250mg/5mL), which is used to treat Clostridioides difficile-associated diarrhoea (or C diff), as well as the bacteria Staphylococcus aureus, which causes enterocolitis.
In an official statement, the ministry notes that oral vancomycin is packaged in 80 mL, 150 mL, or 300 mL pack sizes. Four lots of the medication is the subject of the recall notice, 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 2 grams per day of Vancomycin Hydrochloride for oral solution, USP 250 mg/5mL, may receive up to 4 grams of oral vancomycin per day,” the health ministry explains.
It warns: “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.”
A bottle of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL. [Image courtesy GoodRX]
This recalled product—Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL—is not registered for sale in Trinidad and Tobago. However, the health ministry says it is acting out of an abundance of caution and issuing the advisory:
“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.”
Vancomycin Hydrochloride for Oral Solution, USP is administered for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by C. difficile.
The public can access additional Information on the recall notice by contacting the Office of the Drug Inspectorate via email at drug.inspectoratett@gmail.com, or by phone at 217-4664 (ext. 13404).