D-0589-2024Class II

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

8202 tubes

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Risk Management & CAPA

Reason for recall

CGMP Deviations

Product description

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

Code / lot info

Lot: a) 107IV, Exp: 04/30/2025 b) 107NU, Exp: 06/30/2025; 109NU, Exp: 10/31/2025 c) 117BU, Exp: 10/31/2025 d) 113SA, Exp: 06/30/2025; 114SA, Exp: 10/31/2025 e) 106BR, Exp: 04/30/2025; f) 101MO, Exp: 05/31/2025

Other recalls SPEQ maps to Risk Management & CAPA

2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.

See all Risk Management & CAPA 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.