Health product recall

Cromolyn eye drops: Out of specification (Antimicrobial efficacy)

Brand(s)
Last updated

Summary

Product
Cromolyn eye drops
Issue
Health products - Product quality
What to do

Do not use the affected product. Return it to your local pharmacy for proper disposal. Consult a health care professional if you have used this product and have health concerns.

Affected products

Brand

Product Name

Market Authorization

Dosage Form

Strength

Lot numbers

Pendopharm

Cromolyn eye drops

DIN 02009277

Solution

Cromolyn sodium 2%

221021*, 231034*, 240517*, 230728, 230729, 240210, 240211
5 mL bottle (marked with *) or 10 mL

Issue

Out of specification antimicrobial efficacy analysis (AET) result obtained in stability for affected lots.

What you should do

  • Do not use the affected product. Return it to your local pharmacy for proper disposal.
  • Consult a health care professional if you have used this product and have health concerns.
  • Contact Pendopharm Division of Pharmascience Inc. by calling 1-888-550-6060 or emailing medinfo@pendopharm.com if you have questions about this recall.
  • Report any health product-related side effects or complaints to Health Canada.

Additional information

Background

Depth of recall: Retailers

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies

PENDOPHARM DIVISION OF PHARMASCIENCE INC

100, 6111 Royalmount Ave, 

Montréal, QC, H4P 2T4

Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-76185
Media and public enquiries

Media Enquiries:

Health Canada

613-957-2983

media@hc-sc.gc.ca

Public Enquiries:

613-957-2991

1-866-225-0709

info@hc-sc.gc.ca

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