Pharmascience Inc. recalls one lot of prescription antifungal drug PMS-Nystatin Oral Suspension: Product may pose a choking risk

Starting date:

January 17, 2020

Posting date:

January 17, 2020

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Identification number:

RA-72143

Last updated: 2020-01-17

• 
  Issue
• 
  Products affected
• 
  What you should do
• 
  Who is affected
• 
  Media enquiries
• 
  Public enquiries
• 
  What Health Canada is doing
• 
  Images

Summary

• Product: PMS-Nystatin Oral Suspension 100,000 units/mL (DIN 00792667), Lot 681044, Expires 30-11-2021.
• Issue: Product may contain clumps or jelly-like material, which may lead to choking. Newborns, infants and people with difficulty swallowing are particularly at risk.
• What to do: If, even after the product is shaken well, your product still contains clumps greater than 1 millimetre in size or jelly-like material, return it to your pharmacy for safe disposal and to obtain a replacement.

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.

Products affected

PMS-Nystatin Oral Suspension 100,000 units/mL (DIN 00792667), Lot 681044, Expires 30-11-2021.

What you should do

• Check whether your product is from the affected lot. If, even after the product is shaken well, the product still contains clumps greater than 1 millimetre in size (the size of a poppy seed) or jelly-like material, return it to your pharmacy for safe disposal and to obtain a replacement. Note: the product normally contains small visible particles even after it is shaken well, but the particles should not be greater than 1 millimetre in size.
  • If you are unable to identify the lot number (i.e., you received the product in a bottle other than the one shown in the photo below), and you have concerns about your product, contact your pharmacist.
• Contact Pharmascience Medical Information by calling toll-free at 1-888-550-6060, or by emailing at med.info@pharmascience.com, if you have any questions about this issue.
• Report any health product adverse events or complaints to Health Canada.

Who is affected

Consumers who have bought or who are using the affected product Newborns, infants and people with difficulty swallowing are particularly at risk.

Media enquiries

Health Canada

(613) 957-2983

hc.media.sc@canada.ca

Public enquiries

(613) 957-2991

1-866 225-0709

hcinfo.infosc@canada.ca

What Health Canada is doing

Health Canada is monitoring the effectiveness of the company's recall and verifying that the company takes the necessary steps to prevent this issue from reoccurring.

Images

Select thumbnail to enlarge - opens in a new window