| Type of Product |
Medicine |
| TGA Recall Reference |
RC-2022-RN-00625-1 |
| Product Name/Description |
Baby Bum Mineral SPF50+ Lotion
Lot numbers: N1118B and N1118C
Expiry date: 04/2024
ARTG 355134 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/04/2022 |
| Responsible Entity |
|
| Reason/Issue |
Sun Bum are informing of benzene contamination in one of the raw materials has led to low level contamination of some sunscreen finished goods. Two lot numbers 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 the Baby Bum products. The two lot numbers have been distributed to pharmacies and retailers since 1 August 2021. |
| Recall Action |
Recall |
| Recall Action Instructions |
Sun Bum are advising:
Distributors and Retailers:
- Inspect the stock immediately and quarantine affected stock.
- Follow disposal or return instructions outlined in the customer letter (will be provided only to the impacted customers) for the credit.
Consumers:
- Stop using the affected product.
- Visit the Baby Bum recall website at babybumrecallanz.com to request a refund and then discard the product.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 95 3664 - Customer service - Sun Bum |