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

Starting date:
December 21, 2018
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Labelling and Packaging, Important Safety Information
Audience:
General Public
Identification number:
RA-68632

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. 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 druginfo@tevacanada.com 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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