| Type of Product |
Medicine |
| TGA Recall Reference |
RC-2022-RN-00414-1 |
| Product Name/Description |
Nivea Sun Protect and Moisture Lotion SPF 30 200ml
Product code: 85616
Batch number: 12640440-BN
Expiry date: 06/2024
Nivea Sun Protect and Moisture Roll-on SPF 50 plus 65ml
Product code: 86098
Batch number: 12669940BN
Expiry date: 06/2024
AUSTL 270876 and AUSTL 286352 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/04/2022 |
| Responsible Entity |
|
| Reason/Issue |
Beiersdorf Australia 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. Two 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 NIVEA Sun Protect & Moisture SPF30 Lotion 200ml or Nivea Sun Protect and Moisture Roll-on SPF 50 plus 65ml. The two batches have been distributed to pharmacies and retailers since September 2021. |
| Recall Action |
Recall |
| Recall Action Instructions |
Distributors and Retailers:
- Distributors and retailers are to quarantine affected product for shelf in stores and check stock on hand in warehouses.
- Seek disposal or return instructions from Beiersdorf Australia Customer Service.
- Inform customers
Consumers:
- Consumers are to stop using and dispose of the affected product.
- Consumers are asked to contact Beiersdorf Australia customer service line to arrange for a credit on 1800 103 023 or visit www.nivea.com.au/highlights/nivea-sun-recall
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
(02) 9888 0853 - Customer Service Manager |