Multi event Drug Recall Enforcement Report Class I voluntary initiated by SYNCHRONICITY SPA INC, DBA SUNTE, originally initiated on 05-24-2024 for the 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 The product was recalled due to microbial contamination of non-sterile products: presence of aspergillus sydowii (mold). The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0588-2024 | 05-24-2024 | 07-17-2024 | Class I | 1,902 tubes | 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 | Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold) | Ongoing |
| D-0589-2024 | 05-24-2024 | 07-17-2024 | Class II | 8202 tubes | 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 | CGMP Deviations | Ongoing |
Recalled Products
