D-0588-2024Class I

SYNCHRONICITY SPA INC, DBA SUNTE

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2024-07-17

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

Firm state

Product quantity

1,902 tubes

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Environmental Monitoring

Reason for recall

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

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

Code / lot info

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

Other recalls SPEQ maps to Environmental Monitoring

2026-07-22Class IArgon Medical Devices, Inc 2026-07-22Class IIOlympus Corporation of the Americas 2026-07-22Class IIChiesi USA, Inc.2026-07-22Class IICareFusion 213, LLC

See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.