Novartis Consumer Health Canada Inc. issues voluntary recall of certain over-the counter products due to closure defect

Buckley’s^®

• Buckley’s Complete^® Liquid 150 mL
• Buckley’s Complete^® Liquid 250 mL
• Buckley's Complete^® PM Nighttime Liquid 150 mL
• Buckley’s Complete^® plus Mucus Relief Extra Strength Liquid 150 mL
• Buckley’s Complete^® plus Mucus Relief Extra Strength Liquid 250 mL

Jack & Jill^®

• Jack & Jill^® Bedtime 100 mL Syrup
• Jack & Jill^® Cough & Cold 100 mL Syrup
• Jack & Jill^® Children’s Formula Cough Liquid 100 mL Syrup
• Jack & Jill^® Expectorant 100 mL Syrup
• Jack & Jill^® Cough Syrup 100 mL

NeoCitran^®

• NeoCitran^® Extra Strength Daytime Total Cold & Flu 245 mL Syrup
• NeoCitran^® Extra Strength Nighttime Total Cold & Flu 245 mL Syrup
• NeoCitran^® Extra Strength Chest Congestion, Cold & Mucus Relief 245 mL Syrup

Triaminic^®

• Triaminic^® Long Acting Cough 100 mL Syrup
• Triaminic^® Chest & Nasal Congestion 100 mL Syrup
• Triaminic^® Cough & Sore Throat 100 mL Syrup
• Triaminic^® Total Cold, Cough & Fever 100 mL Syrup
• Triaminic^® Cold & Nighttime Cough 100 mL Syrup
• Triaminic^® Cold & Cough 100 mL Syrup

Follow this process:

1. Go to the website www.novartisOTCCanada.com and follow the instructions
2. Print the Product Returns Form
3. Complete the form in detail
4. Follow the Mailing Directions (on page 2) for detailed instructions on how to ship your product to Novartis Consumer Health Canada Inc. and to ensure that Novartis is billed directly for your shipment. Remember to include the completed form, unexpired product, and receipt of product purchase (if available) in your package.
5. Please allow 8 – 12 weeks for the reimbursement to be processed and sent

NCH Canada is voluntarily recalling Triaminic^® and Jack & Jill^® pediatric syrups and adult Buckley’s Complete^® liquids and NeoCitran^® syrups because the child-resistant feature of the bottle cap may not function properly, enabling the cap to be removed when the tamper-evident seal is still in place.

• Buckley’s Complete^® Liquid 150 mL
• Buckley’s Complete^® Liquid 250 mL
• Buckley's Complete^® PM Nighttime Liquid 150 mL
• Buckley’s Complete^® plus Mucus Relief Extra Strength Liquid 150 mL
• Buckley’s Complete^® plus Mucus Relief Extra Strength Liquid 250 mL
• NeoCitran^® Extra Strength Daytime Total Cold & Flu 245 mL Syrup
• NeoCitran^® Extra Strength Nighttime Total Cold & Flu 245 mL Syrup
• NeoCitran^® Extra Strength Chest Congestion, Cold & Mucus Relief 245 mL Syrup
• Triaminic^® Long Acting Cough 100 mL Syrup
• Triaminic^® Chest & Nasal Congestion 100 mL Syrup
• Triaminic^® Cough & Sore Throat 100 mL Syrup
• Triaminic^® Total Cold, Cough & Fever 100 mL Syrup
• Triaminic^® Cold & Nighttime Cough 100 mL Syrup
• Triaminic^® Cold & Cough 100 mL Syrup
• Jack & Jill^® Bedtime 100 mL Syrup
• Jack & Jill^® Cough & Cold 100 mL Syrup
• Jack & Jill^® Children’s Formula Cough Liquid 100 mL Syrup
• Jack & Jill^® Expectorant 100 mL Syrup
• Jack & Jill^® Cough Syrup 100 mL

No. These other products or formats are not included in this recall – only the following products are being recalled:

• Buckley’s Complete^® Liquid 150 mL, 250 mL
• Buckley’s Complete^® PM Nighttime Liquid 150 mL
• Buckley’s Complete^® plus Mucus Relief Extra Strength Liquid 150 mL, 250 mL
• NeoCitran^® Extra Strength Daytime Total Cold & Flu Syrup 245 mL
• NeoCitran^® Extra Strength Nighttime Total Cold & Flu Syrup 245 mL
• NeoCitran^® Extra Strength Chest Congestion, Cold & Mucus Relief Syrup 245 mL

This product is not included in this recall. The Buckley’s Complete^® 350 mL is not designed to contain a child resistant closure, so it is not affected by the tamper-evident seal malfunction.

We initiated a voluntary recall to consumers, retail customers and wholesalers because the child-resistant feature of the bottle cap may not function properly, enabling the cap to be removed with the tamper-evident seal still in place.

Novartis Consumer Health Canada, Inc. has not received any adverse events due to the tamper evident seal causing a failure of the child resistant cap. Novartis Consumer Health in the United States received four adverse events for a different product with similar packaging related to this issue.

Novartis Consumer Health Canada, Inc. has not received any adverse events due to the tamper evident seal causing a failure of the child resistant cap. Novartis Consumer Health in the United States received four adverse events for a different product with similar packaging related to this issue.

Novartis Consumer Health Canada, Inc. has not received any adverse events due to the tamper evident seal causing a failure of the child resistant cap. Novartis Consumer Health in the United States received four adverse events for a different product with similar packaging related to this issue.

Yes, Triaminic^® and Jack & Jill^® pediatric syrups and adult Buckley’s Complete^® liquids and NeoCitran^® syrups continue to be safe and effective when used as directed on the package label. However, for the identified products, it is possible the child-resistant feature of the bottle cap may not function properly, enabling the cap to be removed with the tamper-evident seal still in place. As a precaution, we are instructing consumers to return the product for a full refund.

Triaminic^® and Jack & Jill^® pediatric syrups and adult Buckley’s Complete^® liquids and NeoCitran^® syrups continue to be safe and effective when used as directed on the package label. However, for the identified products, it is possible the child-resistant feature of the bottle cap may not function properly, enabling the cap to be removed with the tamper-evident seal still in place. As a precaution, we are instructing consumers to return the product for a full refund.

Triaminic^® and Jack & Jill^® pediatric syrups and adult Buckley’s Complete^® liquids and NeoCitran^® syrups continue to be safe and effective when used as directed on the package label. However, for the identified products, it is possible the child-resistant feature of the bottle cap may not function properly, enabling the cap to be removed with the tamper-evident seal still in place. As a precaution, we are instructing consumers to return the product for a full refund.

If you have any questions or your child is experiencing an adverse event, you should contact your physician or healthcare provider as soon as possible. If you need to report an adverse drug event, please contact the Novartis Consumer Relationship Centre at 1-866-513-6742.

No, this is not necessary unless your child has experienced an adverse event. If you have any questions or if your child experienced an adverse event, you should contact your physician or healthcare provider as soon as possible. If you need to report an adverse drug event, please contact the Novartis Consumer Relationship Centre at 1-866-513-6742.

If you have any questions or your child is experiencing an adverse event, you should contact your physician or healthcare provider as soon as possible. If you need to report an adverse drug event, please contact the Novartis Consumer Relationship Centre at 1-866-513-6742.

We regret that some of our products may be unavailable to consumers for a period of time. We are working to remedy the situation and return products to shelves as quickly as possible.