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Health Canada Health products

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

Issued October 4, 2020
Issue
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. Media enquiries Public enquiries 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 .