Drug product
suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, NDC: 69949-152-01 UPC 854245006187
D-0588-2024
Product summary
- Event
- Event 94737
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 1,902 tubes
- Official record key
drug-enforcement:D-0588-2024
Official wording
Reason: Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
Code information: Lot#: 115BU, Exp: 06/30/2025;
Distribution pattern: Distributed Nationwide in the USA and Queensland, Christchurch, Ontario, Quebec, Alberta, British Columbia Cayman Islands, Bermuda, France, Amsterdam, Hants, Dubai, Hong Kong, Singapore, Taiwan
Derived failure modes
-
Microbial contamination
Microbial Contamination