FDA Recall D-0588-2024

SYNCHRONICITY SPA INC, DBA SUNTE · Las Vegas, NV

Class I — life-threatening Ongoing 720 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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

Lot / code: Lot#: 115BU, Exp: 06/30/2025;

Quantity: 1,902 tubes

Reason for recall

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

Recall record

Recall number: D-0588-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
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
Recall initiated: 2024-05-24
Classified by FDA Center: 2024-07-08
FDA published: 2024-07-17
Recalling firm: SYNCHRONICITY SPA INC, DBA SUNTE
Firm location: Las Vegas, NV

Drug identification

Brand name(s): IMPECCABLE SKIN - IVORY
Generic name(s): ZINC OXIDE
Manufacturer(s): Synchronicity Spa, Inc. DBA Suntegrity
NDC(s): 69949-151, 69949-152, 69949-153, 69949-154, 69949-155, 69949-156, 69949-157
Route(s): TOPICAL

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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