VOLUNTARY RECALL - One (1) Lot (150261) of EQUATEtm LENS CARE SYSTEM (DIN 02387638) and EQUATEtm MULTI-PURPOSE SOLUTION (DIN 02291126) Due to a Labelling Error; Distributed by Teva Canada Limited

- Canadian Market Only -

TORONTO, Dec. 17, 2018 /CNW/ - Teva Canada Limited, with the knowledge of Health Canada, is initiating a nationwide voluntary Type II recall of one (1) lot (listed above) of EQUATEtm LENS CARE SYSTEM which is incorrectly labelled on the bottle as EQUATEtm MULTI-PURPOSE SOLUTION. The outer carton (that the bottle is packaged in) is correctly labelled as EQUATEtm LENS CARE SYSTEM. As result of the labelling error, both products with the same lot number (listed below) are being recalled.

Affected Products

This recall does not affect any other lots of EQUATEtm LENS CARE SYSTEM and/or EQUATEtm MULTI-PURPOSE SOLUTION distributed by Teva Canada Limited.

One (1) lot number (listed above) of EQUATEtm LENS CARE SYSTEM and EQUATEtm MULTI-PURPOSE SOLUTION is being recalled due to a labelling error.  The outer carton is correct indicating the product is EQUATEtm LENS CARE SYSTEM, a 3.3% hydrogen peroxide cleaning and disinfecting solution not to be used for rinsing, but the bottle is incorrectly labelled as EQUATEtm MULTI-PURPOSE SOLUTION, a 0.0001% w/v polyhexanide based disinfecting solution for rinsing. The labelling error could cause consumers to use the product in a way that is not intended (such as rinsing of contact lenses before insertion) and could result in a stinging sensation, burning and/or irritation in the eyes; temporary adverse health consequences which may require medical treatment.

What to Do

• Check the lot number (listed above) on the bottle and/or outer carton: Consumers who have purchased either EQUATEtm LENS CARE SYSTEM or EQUATEtm MULTI-PURPOSE SOLUTION are asked to check the lot number (listed above) on the bottle and/or outer carton it is packaged in. If it has lot number (listed above), they are advised to stop using the product and return it to the pharmacy/store where they purchased it.
  
  
• If after inserting contact lenses a stinging sensation occurs, remove lenses from eyes immediately and thoroughly rinse eyes with running water for a few minutes.
  
  
• If burning and/or irritation of the eyes persist, seek assistance from an eye care practitioner.

The Products
Both over-the-counter (OTC) products are used to clean contact lenses and are sold in Canada. EQUATEtm LENS CARE SYSTEM is a sterile solution used for cleaning, disinfecting, protein removal, lubrication and storage of all soft contact lenses. It contains 3.3% hydrogen peroxide and it should not be used for rinsing. The EQUATEtm MULTI-PURPOSE SOLUTION is also a sterile disinfectant, used for all soft contact lenses. Its main ingredient is polyhexanide 0.0001% w/v and its usage, as detailed on the bottle label, is very similar to the EQUATEtm LENS CARE SYSTEM. The major difference consists in usage of the multi-purpose solution for rinsing contact lenses before insertion (which is contraindicated for the lens care system).

The affected product lot includes 996 bottles manufactured in December 2017 with an expiry date of December 5, 2020.  It was first distributed in Canada on August 20, 2018.  

Teva Canada Limited is notifying its distributors, retailers and health care professionals to arrange for the return / reimbursement of any returned recalled product lot.  Distributors and retailers that have inventory of the recalled product have been advised to immediately stop distribution and isolate remaining quantities in their control and return the recalled product lot to Teva Canada Limited.

Medical Questions or Side Effects
This Public Communication is not intended as medical advice. In order to understand the implications of this information to your health, it is important that you consult your eye care practitioner, doctor or health care professional.

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of unexpected side effects in patients using EQUATEtm LENS CARE SYSTEM and EQUATEtm MULTI-PURPOSE SOLUTION should be reported to Teva Canada and/or Health Canada.    

Teva Canada:
Medical Affairs & Drug Information
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
1-800-268-4127, Option 3
[email protected]

Health Canada:

You can report any suspected adverse reactions associated with the use of health products to Health Canada:

• Call Toll-Free: 1-866-234-2345
• Online: www.healthcanada.gc.ca/medeffect
• Fax Toll-Free: 1-866-678-6789
• Mail:
  Canada Vigilance Program
  Marketed Health Products Directorate
  Health Canada, Postal Locator 0701E
  Ottawa, Ontario
  K1A 0K9

Teva Canada Limited
For over 50 years, Teva Canada Limited has been part of the fabric of Canadian families by providing affordable healthcare solutions in the form of over-the-counter and prescription products. This trust and legacy is built on Teva Canada's patient focus and on the assurance it will deliver products of the highest quality. The company takes recalls of this nature very seriously and has commenced a full review of the manufacturing processes that led to the labelling error. Corrective actions will be implemented to prevent any future labelling errors.

This recall is being conducted with the full knowledge of Health Canada.

SOURCE Teva Canada Limited