suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Ne...
FDA Recall #D-0588-2024 — Class I — May 24, 2024
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
Reason for Recall
Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
Recalling Firm
SYNCHRONICITY SPA INC, DBA SUNTE — Las Vegas, NV
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
1,902 tubes
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
Code Information
Lot#: 115BU, Exp: 06/30/2025;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated