Recalls / Class I
Class ID-0588-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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
- Brand name
- Impeccable Skin - Ivory
- Generic name
- Zinc Oxide
- Active ingredient
- Zinc Oxide
- Route
- Topical
- NDCs
- 69949-151, 69949-152, 69949-153, 69949-154, 69949-155, 69949-156, 69949-157
- FDA application
- M020
- Affected lot / code info
- Lot#: 115BU, Exp: 06/30/2025;
Why it was recalled
Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
Recalling firm
- Firm
- SYNCHRONICITY SPA INC, DBA SUNTE
- Manufacturer
- Synchronicity Spa, Inc. DBA Suntegrity
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2411 Tech Center Ct Ste 104, N/A, Las Vegas, Nevada 89128-0805
Distribution
- Quantity
- 1,902 tubes
- 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
Timeline
- Recall initiated
- 2024-05-24
- FDA classified
- 2024-07-08
- Posted by FDA
- 2024-07-17
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0588-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.