D-0588-2024 Class I Ongoing
FDA drug recall D-0588-2024 was initiated by SYNCHRONICITY SPA INC, DBA SUNTE on May 24, 2024 and is designated Class I. Reason for recall: Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold) The recall status is ongoing. Affected quantity: 1,902 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- July 17, 2024
- Initiation Date
- May 24, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,902 tubes
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
Reason for Recall
Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
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
Code Information
Lot#: 115BU, Exp: 06/30/2025;