Two lots of Advil Cold & Sinus Day/Night Convenience Pack recalled due to labelling error that may cause confusion between daytime and nighttime tablets

Starting date:

October 3, 2021

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Labelling and Packaging, Product Safety

Audience:

General Public

Identification number:

RA-76571

Last updated:
2021-10-03

Summary

• Product:
  Advil Cold & Sinus Day/Night Convenience Pack, in boxes of 18 caplets and 36 caplets
• Issue:
  GSK is recalling two lots (ER2072, ER2069, expiry 2023-02) due to a labelling error on the back of the blister pack. Consumers may take a nighttime caplet instead of a daytime caplet, and vice versa. Taking a nighttime caplet when alertness is required may pose health risks.
• What to do:
  Stop using the recalled products. Consult a health care professional if you have used any of these products and have health concerns.

• 
  Issue
• 
  What you should do
• 
  Media enquiries
• 
  Public enquiries
• 
  Images

Affected products

Issue

GlaxoSmithKline Consumer Healthcare ULC (GSK) is recalling two lots of Advil Cold & Sinus Day/Night Convenience Pack (one lot of 18 caplet boxes and one lot of 36 caplet boxes) due to a labelling error on blister packs. The foil backing on the blister pack is rotated upside down and misaligned, so the nighttime caplets are labelled as daytime caplets, and some daytime caplets are labelled as nighttime caplets. Consumers may take a nighttime caplet when they intend to take a daytime caplet, and vice versa.

The daytime and nighttime caplets have a different shape and colour (the daytime caplet is beige and has the marking ‘ADVIL COLD & SINUS’ in black ink. The nighttime caplet is orange and has the marking ‘Advil A/S’). The nighttime caplets contain an antihistamine medicinal ingredient (chlorpheniramine maleate) that can cause drowsiness. Taking a nighttime caplet when alertness is required may pose potentially serious adverse health consequences, such as when driving motor vehicles or operating heavy machinery. It may also cause potentially serious health consequences for those who have taken other sedatives or tranquilizers, consumed alcohol, and the elderly.

The affected products were distributed in Canada starting July 2021.

Health Canada is monitoring the company’s recall and implementation of any necessary corrective and preventive actions.

What you should do

• Stop using the recalled products. Consult a health care professional if you have used any of these products and have health concerns.
  • Follow municipal or regional guidelines on how to dispose of chemicals and other hazardous waste; or
  • Return the product to your local pharmacy for proper disposal.
• Contact GSK by calling 1-855-367-7349, or emailing ca.customer-relations@gsk.com, if you have questions about the recall.
• Report any health product-related side effects or complaints to Health Canada.

Media enquiries

Health Canada

613-957-2983
media@hc-sc.gc.ca

Public enquiries

613-957-2991

1-866-225-0709
hcinfo.infosc@canada.ca

Images

Select thumbnail to enlarge - opens in a new window