| Type of Product |
Medicine |
| TGA Recall Reference |
RC-2022-RN-00653-1 |
| Product Name/Description |
2XP SPF50+ BRONZE PROTECT SUNSCREEN LOTION
Batch number: 1102889
Expiry date: 01/2024
ARTG 294158
(2XP SPF50+ BRONZE PROTECT SUNSCREEN LOTION) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/05/2022 |
| Responsible Entity |
|
| Reason/Issue |
Ensign Laboratories is informing that benzene contamination in one of the raw materials (C12-15 alkyl benzoate) has led to low level contamination of some sunscreen finished goods. Three batches containing the contaminated material had benzene above the acceptable limit, however only one was distributed (1102889).
Benzene is a Class 1 residual solvent, which should not be employed in the manufacture of drug substances, excipients, and drug products because of its unacceptable toxicity (it is a recognised carcinogen).
This action does not affect any other batches of 2XP sunscreen. |
| Recall Action |
Recall |
| Recall Action Instructions |
Consumers are advised to stop use of the affected product. Customers should return any affected product to the place of purchase for a refund or call the Customer Service Line on 03 8586 2100 to arrange the return of the affected product and refund.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
03 8586 2100 - Heritage Brands Customer Service |