Health Canada has alerted consumers to a recall of one lot of a prescription antifungal drug called PMS-Nystatin Oral Suspension over a potential choking risk associated with the product.
On Jan. 17, Health Canada issued a release advising Canadians that Pharmascience Inc. is recalling one lot of PMS-Nystatin Oral Suspension because the product may contain clumps or jelly-like material that pose a choking risk to newborns, infants and individuals who have difficulty swallowing, even if it is shaken well before use.
The affected product is PMS-Nystatin Oral Suspension 100,000 units/mL (DIN 00792667). The recalled lot number is 681044 and has an expiration date of Nov. 30, 2021. This affected lot was reportedly distributed throughout Canada beginning in July 2019.
Pharmascience alerted Health Canada after it had received multiple complaints about the affected lot. Health Canada conducted laboratory tests of the product samples and also identified jelly-like material in the medication. However, Health Canada notes that it has not yet received reports of adverse events related to the issue.
According to Health Canada, Nystatin is a prescription antifungal medication used for the treatment and prevention of fungal infections in the mouth, esophagus, stomach and intestinal tract.
If you currently have a Nystatin prescription in your possession, check the label to see if the product is from the affected lot. If the medication contains jelly-like material or clumps greater than 1 millimetre in size even after the product is shaken well, you can return it to your pharmacy and get a replacement product.
Health Canada notes that Nystatin normally contains small visible particles even after it has been shaken well to mix the drug evenly. However, these particles should be no larger than a poppy seed.
If you have questions about the Nystatin recall or the potential choking risk associated with the product, you can contact Pharmascience Medical Information by calling 1-888-550-6060 or emailing [email protected]. Contact your pharmacist if you are unable to identify the lot number and have concerns about the medication.
If you or a loved one experience choking or any other adverse effects while using Nystatin, you can report them to Health Canada.
“Health Canada is responsible for helping Canadians maintain and improve their health,” the Health Canada section of Canada.ca says. “It ensures that high-quality health services are accessible, and works to reduce health risks.”
Health Canada is currently monitoring the Nystatin recall to verify that Pharmascience is taking measures necessary to ensure the quality of their medication and prevent the issue from occurring again in the future.
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One thought on Pharmascience Recalls Prescription Nystatin Antifungal Drug
I have I have yeast infections often and use this to cure it. I have lupus so I use antibiotics a lit which causes bad yeast infections