FDA recall D-0589-2024

SYNCHRONICITY SPA INC, DBA SUNTE · Class II · drug

Product

suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple Shades, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, a) NDC: 69949-151-01, UPC: 854245006170 - IVORY b) NDC: 69949-156-01, UPC: 854245006224 - NUDE c) NDC: 69949-152-01, UPC: 854245006187 - BUFF d) NDC: 69949-153-01, UPC: 854245006194 - SAND e) NDC: 69949-155-01, UPC: 854245006217 - BRONZE f) NDC: 69949-157-01, UPC: 854245006446 - MOCHA

Reason for recall

CGMP Deviations

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

Key facts

Status
Ongoing
Initiation date
2024-05-24
Report date
2024-07-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Las Vegas, NV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0589-2024