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Recall Observatory FDA recall evidence

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

May 24, 2024

Class I

Product summary

Firm
SYNCHRONICITY SPA INC, DBA SUNTE
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

    reason.microbial_contamination · v1.0.0

    Microbial Contamination