Why it was recalled
Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
Product description
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
Lot numbers, UPCs & expiration codes
Lot#: 115BU, Exp: 06/30/2025;
Where it was sold
Distributed Nationwide in the USA and Queensland, Christchurch, Ontario, Quebec, Alberta, British Columbia Cayman Islands, Bermuda, France, Amsterdam, Hants, Dubai, Hong Kong, Singapore, Taiwan
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0588-2024
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- May 24, 2024
- FDA report date
- Jul 17, 2024
- Quantity
- 1,902 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SYNCHRONICITY SPA INC, DBA SUNTE
Original FDA data
Every field from FDA enforcement report D-0588-2024, exactly as published.
Show all FDA fields
- City
- Las Vegas
- State
- NV
- Status
- Ongoing
- Country
- United States
- Event ID
- 94737
- Address
- 2411 Tech Center Ct Ste 104
- Code information
- Lot#: 115BU, Exp: 06/30/2025;
- Postal code
- 89128-0805
- Report date
- Jul 17, 2024
- Product type
- Drugs
- Recall number
- D-0588-2024
- Classification
- Class I
- Recalling firm
- SYNCHRONICITY SPA INC, DBA SUNTE
- Product quantity
- 1,902 tubes
- Reason for recall
- Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- 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
- Recall initiation date
- May 24, 2024
- Initial firm notification
- Letter
- Center classification date
- Jul 8, 2024