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.
Related recalls and alerts
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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