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TGA Action ID	RC-2026-RN-00700-1
Type of Product	Medical Device
Product Name/Description	LULA Nicotine Salt Pods - Tobacco 0 mg/mL Batch: 20250630, 20251128 Expiry: 30 June 2027, 30 November 2027 Supplied via SAS pathway
ARTG Number
Action Type	Recall
Action Level	Retail
Hazard Classification	Class III
Reason for the Action	Testing has identified low levels of nicotine, with results of 0.103 mg/mL and 0.116 mg/mL, in product labelled “nicotine 0 mg/mL”. At the concentration identified, based on the available information, clinically significant nicotine-related effects during use are considered unlikely. However, mild and transient nicotine-related effects cannot be completely excluded. Potential consequences include transient nicotine-related symptoms in particularly sensitive or nicotine-naive users, such as nausea, dizziness, headache, throat discomfort, increased heart rate or palpitations. No adverse events associated with the affected batches have been reported to date.
Instructions for Customers/Users	Customers are to: · cease supply of the affected batches; · identify and segregate any remaining affected stock held at their pharmacy; · clearly mark or otherwise identify it as being quarantined; · return affected stock. A full credit will be provided for any and all affected stock.
Action Commencement Date	15/10/2026
Responsible Entity	Bay Pharma Pty Ltd
Contact Information	1300 938 651 - Bay Pharma