Drug product
CeraVe Healing Lip Balm/SPF 30 (avobenzone 3%, dimethicone 1%, homosalate 10%, octisalate 5%, octocrylene 10%, Net Wt. 0.15 oz. (4.25 g) stick, CeraVe LLC., New York, NY 10001, UPC 3 01872 49201 7.
D-0071-2019
Product summary
- Event
- Event 80750
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25,596 sticks
- Official record key
drug-enforcement:D-0071-2019
Official wording
Reason: Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcus aureus.
Code information: Lot: PSP85W/172792H
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Microbial contamination
Microbial Contamination