Drug product
DERMATONE (titanium oxide 6% and zinc oxide 4.7%) No-Touch Sunscreen Stick, SPF 50, Net Wt. 0.49 oz. (13.9g) stick, Distributed by: Beaumont Products, Inc. Kennesaw, GA 30144, UPC 0 20908 05100 3.
D-0027-2019
Product summary
- Event
- Event 80750
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5025 sticks
- Official record key
drug-enforcement:D-0027-2019
Official wording
Reason: Microbial Contamination of Non-Sterile Products: sample tested positive for Staphylococcus aureus.
Code information: Lot: 172428G
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Microbial contamination
Microbial Contamination