Recalls of Regener-Eyes Ophthalmic Solution and Regener-Eyes Ophthalmic Solution Lite

Starting date:

October 30, 2020

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information, Unauthorized products

Audience:

General Public, Healthcare Professionals

Identification number:

RA-74243

Last updated:
2020-10-30

Summary

• Product:
  Regener-Eyes Ophthalmic Solution and Regener-Eyes Ophthalmic Solution Lite (biologic eye drops)
• Issue:
  These unauthorized products claim to contain human placenta materials. Health Canada has not authorized any health products containing human placenta in Canada and they may pose serious health risks.
• What to do:
  Do not use Regener-Eyes Ophthalmic Solution or Regener-Eyes Ophthalmic Solution Lite. Report any health product-related adverse reactions or complaints to Health Canada.

OTTAWA – Health Canada is advising Canadians not to use the unauthorized biologic eye drops Regener-Eyes Ophthalmic Solution and Regener-Eyes Ophthalmic Solution Lite, which claim to contain human placenta materials. Health Canada has not authorized any health product containing human placenta in Canada and they may pose serious health risks.

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).

These eye drops have been found at various locations in Canada, and the Department has previously communicated about this issue. All products and recalling companies can be found in the list of Affected Products table below.

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.

Healthcare professionals should stop prescribing or dispensing Regener-Eyes Ophthalmic Solution and Regener-Eyes Ophthalmic Solution Lite immediately.

The Department is also advising Canadians to:

• Discontinue use of these products immediately. Consult your health care professional if you have used or have been administered these products and have health concerns.
• Report any health product-related adverse reactions or complaints to Health Canada.
• 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 companies to stop importing and selling these unauthorized products. The Department has also directed them to recall Regener-Eyes Ophthalmic Solution and Regener-Eyes Ophthalmic Solution Lite and to notify their clients immediately.

Should any additional recalls be necessary, Health Canada will update the table below and inform Canadians.

Health Canada is sharing information with the provincial and territorial optometric regulatory bodies for further action as appropriate.

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.

Affected Products:

This list may be updated if more companies are found to be selling these eye drops.