GSK Advil Cold & Sinus Day/Night Drug Recall [Canada]


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GSK Advil Cold & Sinus Day/Night Drugs Recall [Canada]

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Canada/Ottawa: GlaxoSmithKline Consumer Healthcare ULC (“GSK”), a Mississauga, Ontario establishment, recalls certain batch/lots of Advil Cold & Sinus Day/Night Convenience Packs from the Canadian marketplace due to suspected mispackaging and/or mislabeling and consequential risks of incorrect dosing, inability to reliably operate machinery, falls, laceration, concussion, bone fractures and/or central nervous system (“CNS”) injury, all serious health and safety hazards requiring immediate medical intervention to minimize pain and suffering as well as prevent life-changing injury.

HCSC: http://ht.ly/RZm330rW4dS

Direct link: https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/76571a-eng.php

Additional information:
Health Canada/Santé Canada (“HCSC”) reports the following Advil Cold & Sinus medications are subject to this recall:

  • Advil Cold & Sinus Day/Night Convenience Packs – large, packaged in boxes containing 36 caplets (24 Daytime and 12 Nighttime doses) with a DIN of 02399733 (for the Convenience Pack), 02267616 (for the Daytime Caplets) and 02267632 (for the Nighttime Caplets). The recalled 36-caplet Convenience Packs have a batch/lot of ER2072 and an expiration date code of 2023-02
  • Advil Cold & Sinus Day/Night Convenience Packs – small, packaged in boxes containing 18 caplets (12 Daytime and 6 Nighttime doses) with a DIN of 02399733 (for the Convenience Pack), 02267616 (for the Daytime Caplets) and 02267632 (for the Nighttime Caplets). The recalled 18-caplet Convenience Packs have a batch/lot of ER2069 and an expiration date code of 2023-02

Please consult the photograph above for details of the product’s packaging, design and retail presentation. Additional images of the recalled Advil Cold & Sinus medications can be found on the Web site above.

==> No barcodes, UPCs, item numbers, best-before date codes, manufacturing date codes, production dates, regulatory approval designations, registration numbers, agency approval designations or other identification numbers were listed with this recall notification.

These Advil Cold & Sinus medications are thought to have been marketed, distributed and sold in all Canadian provinces starting July 2021, although it is always possible these drug products had wider distribution outside the country. When in doubt, please contact the manufacturer for specific product information.

According to Health Canada, GlaxoSmithKline has recalled certain batch/lots of Advil Cold & Sinus Day/Night Convenience Packs from the Canadian marketplace due to suspected mispackaging and/or mislabeling and consequential risks of incorrect dosing.

in this situation, the foil backing on the blister packs containing the medication 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 is marked “ADVIL COLD & SINUS” in black ink while the Nighttime Caplet is orange and has the marking ‘Advil A/S’). The Nighttime Caplets contain an Antihistamine medicinal ingredient (specifically, Chlorpheniramine Maleate) that is known to cause drowsiness.

==> Taking a Nighttime Caplet when alertness is required (i.e., during the waking hours) 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 to older adults.

==> Never depend on your senses of sight, smell, taste or touch to confirm drug poisoning or contamination. If in doubt about the safety of any drug, return it to your retailer for refund or toss it out in your household garbage, making sure pets and small children can’t access the suspect food.

==> If you have a medical emergency, please contact 9-1-1, your closest hospital or emergency center equipped to properly treat drug overdose.

If you have any questions, comments or complaints about this recall, please contact GlaxoSmithKline toll-free at 1-855-367-7349 during normal business hours Eastern Standard Time, Monday to Friday or by e-mail at ca.customer-relations@gsk.com.

If you have any further questions, comments or complaints about this recall, please contact Health Canada toll-free at 1-866-225-0709 or +1-613-957-2991 (local). You can also reach the agency by e-mail at hcinfo.infosc@canada.ca. Working members of the press/media can contact Health Canada at +1-613-957-2983 or by e-mail at media@hc-sc.gc.ca.

Please note: the Canada Consumer Product Safety Act prohibits recalled products from being redistributed, sold or even given away in Canada.

==> To see other recalls and notifications caused by suspected faulty and/or dangerous medications, please search for “drug” using the Search Box at the top of this page.

==> To see other recalls and notifications relating to Bone Fracture hazards, please search for “fracture” using the Search Box at the top of this page.

==> To see other recalls and notifications relating to Concussion or Traumatic Brain Injury (“TBI”) hazards, please search for “concussion” using the Search Box at the top of this page.

==> To see other recalls and notifications relating to Fall hazards, please search for “fall” using the Search Box at the top of this page.

==> To see other recalls and notifications relating to Laceration hazards, please search for “laceration” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by GlaxoSmithKline Consumer Healthcare ULC, please search for “GlaxoSmithKline” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold under the Advil brand, please search for “Advil” using the Search Box at the top of this page.

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More information about this recall:
HCSC ID number: RA-76571
Recalls Direct RIN: 14971-2021
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
==> http://wp.me/P2bVty-2
Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe product you purchased in Canada [external: new window opens]:
==> http://www.hc-sc.gc.ca/cps-spc/advisories-avis/incident/index-eng.php
Search for a recalled product on the Health Canada Web site [external: new window opens]:
==> http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php

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E. & O. E.

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