Status
Ongoing
Drug Enforcement D-0589-2024
CGMP Deviations
Classification
Class II
Report Date
July 17, 2024
Termination Date
—
Product Information
- 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
- Product quantity
- 8202 tubes
- Reason for recall
- CGMP Deviations
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Distributed Nationwide in the USA and Queensland, Christchurch, Ontario, Quebec, Alberta, British Columbia Cayman Islands, Bermuda, France, Amsterdam, Hants, Dubai, Hong Kong, Singapore, Taiwan
Location & Firm
- Recalling firm
- SYNCHRONICITY SPA INC, DBA SUNTE
- Address
-
2411 Tech Center Ct Ste 104, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0589-2024
- Event ID
- 94737
- Recall initiation date
- May 24, 2024
- Center classification date
- July 8, 2024
- Code 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
- More code info
- —