Mix up in packaging; day is night, night is day in Advil Cold & Sinus Convenience Pack
Two lots of Advil Cold & Sinus Day/Night Convenience Pack recalled due to labelling error that may cause confusion between daytime and nighttime tablets
GlaxoSmithKline Consumer Healthcare ULC (GSK) is recalling two lots of Advil Cold & Sinus Day/Night Convenience Pack 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 nighttime caplets contain an antihistamine medicinal ingredient (chlorpheniramine maleate) that can cause drowsiness.
Affected products
Product Name
DIN
Lot #
Expiration Date
Advil Cold & Sinus Day/Night Convenience Pack
Box of 36 caplets (24 daytime and 12 nighttime)
02399733 (convenience pack)
02267616
(daytime caplets)
02267632
(nighttime caplets)
ER2072
2023-02
Advil Cold & Sinus Day/Night Convenience Pack
Box of 18 caplets (12 daytime and 6 nighttime)
ER2069
2023-02
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.
You can report any suspected adverse reactions to drugs and other health products to the Canada Vigilance Program by visiting the Adverse Reaction and Medical Device Problem Reporting page.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html
