ZINC OXIDE Recall D-0588-2024
Description: 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
ZINC OXIDE Recall D-0588-2024 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0588-2024 |
Event ID | 94737 |
Brand | IMPECCABLE SKIN - IVORY |
Generic Name | ZINC OXIDE |
Manufacturer | ZINC OXIDE |
Original Package? | 1 |
Active Substance | ZINC OXIDE |
Drug Route | TOPICAL |
Distribution | Distributed Nationwide in the USA and Queensland, Christchurch, Ontario, Quebec, Alberta, British Columbia Cayman Islands, Bermuda, France, Amsterdam, Hants, Dubai, Hong Kong, Singapore, Taiwan |
Quantity | 1,902 tubes |
Recall Reason | Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold) |
Drug Classification | Class I |
Drug Code Info | 20240717 |
Product NDC | 69949-151 69949-152 69949-153 |
Drug UPC | 854245006187 |
Recall Initiation Date | 20240524 |
Report Date | 20240717 |
Classification Date | 20240708 |
Address | 2411 Tech Center Ct Ste 104N/A Las Vegas, NV 89128-0805 United States |
Recalling Firm | SYNCHRONICITY SPA INC, DBA SUNTE |
Initial Notification | Letter |
Unique Ingredient Identifier | SOI2LOH54Z |
Drug Application Number | M020 |
Structured Product Labeling (SPL ID) | 9013d884-7a0e-4316-960d-a49cdffccf02 |
Structured Product Labeling (SPL Set ID) | 98a7896e-4b03-4184-ac2e-6b49e47c0bc4 |
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