| Type of Product |
Medicine |
| TGA Recall Reference |
RC-2022-RN-00622-1 |
| Product Name/Description |
SPF 50+ Lotion Spray Coconut Beach 200ml
Lot numbers: 2009110050 and 2011240032
Batch numbers: 1104263, 1104743 and 1104264
Expiry dates: May 2024, March 2024 and January 2024
AUST L 354358 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/04/2022 |
| Responsible Entity |
|
| Reason/Issue |
Bondi Sands are informing of benzene contamination in one of the raw materials that has led to low level contamination of some sunscreen finished goods. Three batches containing the contaminated material had benzene above the acceptable limit.
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 Bondi Sands sunscreen. |
| Recall Action |
Recall |
| Recall Action Instructions |
Wholesalers:
- Inspect stock immediately and quarantine affected stock to prevent further distribution.
- If the affected stock has been forwarded to a retail store, contact that retailer with the Customer Letter and the Recall Acknowledgement Form, which they need to fill in and return to you, whether they have affected sunscreen or not.
- Contact Frostbland to arrange for a replacement.
Retailers:
- Inspect and quarantine affected batches immediately.
- Return affected stock on hand to Frostbland (Unit 1, 47-53 Moxon Road, Punchbowl, NSW 2196).
- Contact Frostbland to arrange for a replacement.
Consumers:
- Consumers are advised to stop use of the affected product.
- Please return it to the place of purchase for a refund or call the Bondi Sands Customer Service Line on 1300 961 385 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 |
1300 961 385 - Bondi Sands Customer Service Line |