An unauthorized biologic eye drop, Regener-Eyes Ophthalmic Solution, recalled after Edmonton clinic found to be importing and selling it

Starting date:
October 4, 2020
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Unauthorized products, Important Safety Information
Audience:
General Public, Healthcare Professionals
Identification number:
RA-74073

Last updated:

Summary

  • Product: Regener-Eyes Ophthalmic Solution (biologic eye drop)
  • Issue: This unauthorized product claims to contain human placenta materials. Health Canada has not authorized any health products containing human placenta in Canada, as they may pose serious health risks.
  • What to do: Do not use Regener-Eyes Ophthalmic Solution. Report adverse reactions to Health Canada.

OTTAWA – Health Canada is recalling  an unauthorized biologic eye drop, Regener-Eyes Ophthalmic Solution. The Calgary Trail Vision Centre in Edmonton, Alberta was importing and selling the product. Importing or selling an unauthorized health product is illegal in Canada.

This unauthorized product claims to contain human placenta materials. Health Canada has not authorized any health product containing human placenta in Canada. Human placenta is a biologic material and can contain infectious agents such as bacteria (e.g. Group B Streptococcus) and viruses (e.g. HIV, or hepatitis).

On September 28, 2020, Regener-Eyes Ophthalmic Solution was recalled because it may pose serious risks to the health of consumers.

Health products that have not been authorized by Health Canada have not been assessed for safety, efficacy and quality, and could pose serious health risks.

Health care professionals should stop prescribing or dispensing Regener-Eyes Ophthalmic Solution immediately.

The Department is also advising Canadians to:

  • Not use this product if they have it;
  • Report if they’ve been given this product or if they have any adverse events to Health Canada by calling toll-free at 1-866-234­-2345, or by reporting online, by mail or by fax; and
  • Read product labels to verify that health products have been authorized for sale by Health Canada. Authorized health products have an eight-digit Drug Identification Number (DIN), Natural Product Number (NPN) or Homeopathic Drug Number (DIN-HM). You can also check if products have been authorized for sale by searching Health Canada’s Drug Product Database and Licensed Natural Health Product Database.

What Health Canada is doing

Health Canada has directed Calgary Trail Vision Centre to immediately stop importing and selling unauthorized health products. Importing or selling an unauthorized product is illegal. Health Canada is sharing the information with Alberta’s optometric regulatory bodies for further action as appropriate. The Department will not hesitate to take additional enforcement actions in this case as necessary to protect the health and safety of Canadians.

Health Canada will continue to take action against any companies found to be selling unauthorized health products either online or in stores in Canada. The Department works with the Canada Border Services Agency to help prevent the import of any unauthorized health products and will continue to warn Canadians about these products when they are found in the marketplace. Health Canada works closely with law enforcement agencies and may refer suspected illegal activity to them for further action.

Media enquiries

Health Canada
(613) 957-2983
hc.media.sc@canada.ca

Public enquiries

(613) 957-2991
1-866 225-0709