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Voluntary Recall Notice: Vancomycin Hydrochloride for Oral Solution, USP

The Health Ministry is advising of a voluntary recall notice of four lots of Vancomycin Hydrochloride for Oral Solution, USP.

The recall was issued by Amneal Pharmaceuticals, LLC due to the potential overfilling of bottles.

Due to the potential overfilling, patients who are prescribed the maximum daily dose of up to 2 grams per day, may receive up to 4 grams per day.

As such, 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.

This product 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 recall is for the following sizes: 250 mg/5mL packaged in 80 mL, 150 mL, or 300 mL.

The Ministry says while the recalled products are not registered for sale in T&T, out of an abundance of caution, persons who may be in possession of the recalled products should discontinue use immediately and return the product to the place of purchase where possible..

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