Advisory - One lot of Equate brand Lens Care System and Multi-Purpose Solution voluntarily recalled because of a labelling error

OTTAWA, Dec. 21, 2018 /CNW/ -

Issue
Teva Canada is voluntarily recalling one lot (Lot 150261) of two products because of a labelling error. While the outer carton of Equate brand Lens Care System is correctly labelled, the bottle within the carton is mislabelled as Equate brand Multi-Purpose Solution. Because of the labelling error, the company is recalling both products labelled with Lot 150261.

Image 1: CARTON PACKAGING: Correct exterior packaging of EQUATE™ LENS CARE SYSTEM; Image 2: BOTTLE LABEL: Incorrect label indicating EQUATE™ MULTI-PURPOSE SOLUTION applied to bottles of EQUATE™ LENS CARE SYSTEM (CNW Group/Teva Canada Limited) (CNW Group/Health Canada)

Bottles labelled as Equate Multi-Purpose Solution should contain a 0.0001% w/v polyhexanide based disinfecting solution for rinsing. The mislabelled bottles contain the Equate Lens Care System, which is a 3.3% hydrogen peroxide cleaning and disinfecting solution and should not be used for rinsing. The labelling error could cause consumers to use the product in a way that is not intended, such as rinsing contact lenses before insertion. This could lead to temporary adverse health effects, such as eye stinging, burning or irritation, which could require medical treatment.

Who is affected

• Consumers who have bought or used Equate Lens Care System or Equate Multi-Purpose Solution with Lot 150261.

Affected products

Brand  Name	Product Name	Size	On Bottle and/or  Outer Carton	DIN	UPC
EQUATE	LENS CARE SYSTEM	360 mL	Lot 150261	02387638	628915095111
EQUATE	MULTI-PURPOSE SOLUTION	355 mL	Lot 150261	02291126	628915166156

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

What consumers should do

• Check the lot number on the bottle and/or outer carton to see whether your product is affected. If it has Lot 150261 on the label, stop using the product and return it to the place of purchase.
• As noted by Teva Canada, if a stinging sensation occurs after inserting contact lenses, remove the 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.
• Contact Teva Canada if you have questions about this recall by emailing [email protected] or calling toll-free at 1-800-268-4127, option 3.
• Report any health product-related adverse reactions or complaints to Health Canada.

What Health Canada is doing
Health Canada is monitoring the effectiveness of the company's recall. Should additional safety concerns be identified related to this issue, Health Canada will take appropriate action and inform Canadians as necessary.

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SOURCE Health Canada

Media Enquiries: Health Canada, [phone]; Public Enquiries: [phone], 1-866 225-0709