GSK Recalls Nicotine Lozenges from Warehouses and Distributors

GSK is in the process of voluntarily recalling from warehouses and distributors a number of batches of nicotine lozenges sold globally, after we detected manufacturing issues affecting some batches. In some cases, the lozenges were larger or smaller than GSK’s manufacturing standards.

In Australia, the affected brands include:

• Nicabate Lozenge 2mg (AUST R 81977) – Packs of 36 and 72 Lozenges
• Nicabate Lozenge 4mg (AUST R 81978) – Packs of 36 and 72 Lozenges
• Nicabate Mini Lozenge 1.5mg (AUST R 156603) – Packs of 20 and 60 Lozenges
• Nicabate Mini Lozenge 4mg (AUST R 156604) – Packs of 20 and 60 Lozenges

The health and safety of our consumers is of utmost importance to GSK. We have undertaken a full review of product safety and the manufacturing process and have advised the Therapeutic Goods Administration (TGA), of our actions. GSK is confident our lozenges currently in market do not pose a safety risk.

GSK has also temporarily suspended production and distribution at our manufacturing site in Aiken, South Carolina, where the nicotine lozenge products are produced, and is focused on correcting the manufacturing issues as soon as possible so we can resume production.

We regret the inconvenience of this recall and supply shortage on our customers and consumers and will provide more information where possible. GSK manufactures a variety of nicotine replacement products such as Nicabate gum and patches, or you can contact your healthcare professional to discuss alternatives in the meantime.

Contains nicotine. Stop smoking aid. Use only as directed.

NICABATE is a registered trade mark of the GlaxoSmithKline group of companies.