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D-0589-2024Class II

SYNCHRONICITY SPA INC, DBA SUNTE

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
SYNCHRONICITY SPA INC, DBA SUNTE
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
NV
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
See all Risk Management & CAPA recalls →

Data: U.S. FDA. 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. Open the enforcement explorer →