Drug Enforcement D-0588-2024

Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)

Status

Ongoing

Classification

Class I

Report Date

July 17, 2024

Termination Date

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Product Information

Product 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
Product quantity
1,902 tubes
Reason for recall
Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
Recall initiation reason
—
Initial firm notification
Letter
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

Location & Firm

Recalling firm
SYNCHRONICITY SPA INC, DBA SUNTE
Address
2411 Tech Center Ct Ste 104, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0588-2024
Event ID
94737
Recall initiation date
May 24, 2024
Center classification date
July 8, 2024
Code info
Lot#: 115BU, Exp: 06/30/2025;
More code info
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