GRACE & FIRE PTY LTD: Drug Recall
Recall #D-0641-2025 · 08/22/2025
Class II: Risk
Recall Details
- Recall Number
- D-0641-2025
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- GRACE & FIRE PTY LTD
- Status
- Ongoing
- Date Initiated
- 08/22/2025
- Location
- Cremorne, N/A, Australia
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 44,497 tubes
Reason for Recall
Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
Product Description
Ultra Violette Mini SPF Mates kit includes: Velvet Screen SPF 50 Blurring Mineral SkinScreen, Zinc Oxide 22.75%, 15 mL, 0.5 fl. oz. per tube, Supreme Sunscreen SPF 50, 15 mL 0.5 fl. oz. per tube, Distributed by: Grace & Fire USA Inc., 251 Little Falls Drive, New Castle Wilmington, Delaware 19808, NDC 84803-110-01 (15 mL Velvet Screen), UPC 9355909005757.
Distribution Pattern
Nationwide in the USA
Other Recalls by GRACE & FIRE PTY LTD
- Class II: Risk 08/22/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.