suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Sunt
Summary
The FDA issued a Class I for suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad S by SYNCHRONICITY SPA INC, DBA SUNTE. Reason: Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold).
Details
Source
Drug Recall
External ID
D-0588-2024
Action Date
2024-07-17
Status
Ongoing
Category
drug
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/Code Info: Lot#: 115BU, Exp: 06/30/2025;
Quantity Affected: 1,902 tubes
Reason for Recall
Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
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
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-24
Company
Las Vegas, NV
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 61 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
SYNCHRONICITY SPA INC, DBA SUNTE has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SYNCHRONICITY SPA INC, DBA SUNTE) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SYNCHRONICITY SPA INC, DBA SUNTE have FDA actions?
SYNCHRONICITY SPA INC, DBA SUNTE has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0588-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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