Issue:
Health Canada is advising Canadians that Pharmascience Inc. is recalling one lot of PMS-Nystatin Oral Suspension, because it may contain clumps or jelly-like material that may pose a choking risk. Newborns, infants and people with difficulty swallowing are particularly at risk.
PMS-Nystatin Oral Suspension normally contains small visible particles and, as noted in the user instructions, it should be shaken well before each use to mix the drug evenly. For the affected lot, clumps greater than 1 millimetre (the size of a poppy seed) or jelly-like material may persist even after the product is shaken well.
Nystatin is a prescription antifungal drug for use by newborns, children and adults to treat and prevent fungal (candida) infections in the mouth, esophagus, stomach and intestinal tract.
Pharmascience Inc. notified Health Canada of this issue after receiving multiple complaints of clumps with the affected lot. Health Canada’s laboratory testing of product samples also identified jelly-like material.
The affected lot was distributed throughout Canada starting in July 2019. To date, the company and Health Canada have not received any reports of adverse events involving this issue.
Product: PMS-Nystatin Oral Suspension 100,000 units/mL (DIN 00792667), Lot 681044, Expires 30-11-2021.
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