Apology Regarding Voluntary Recall of "FATUITE Perfect Proof UV Defense" Due to Product Defect

We have recently confirmed that our product, "FATUITE Perfect Proof UV Defense," for which we are the manufacturer and seller, has a high probability of developing crystals inside the product over time. Therefore, after consultation with our client, FATUITE Inc., we have decided to voluntarily recall the said product. As the company responsible for manufacturing and sales, we deeply apologize for the anxiety and inconvenience this has caused our customers and all related parties. ① Details of the Target Product Product Name: FATUITE Perfect Proof UV Defense Target Lot: All sold units of the product and sample pouches. ② Cause and Background Cause The direct cause was the failure to blend two raw materials in the specified quantities. This occurred because the manufacturer proceeded with production using a different formula from the officially approved one, without reflecting the test results of prototypes or feedback from FATUITE Inc. into the manufacturing formula, and without sufficient final confirmation. Furthermore, by neglecting some of the necessary post-manufacturing tests, the incorrect product was shipped. The confirmation of the manufacturing formula and the quality of prototypes are the manufacturer's responsibility, and this incident was caused by a lack of coordination within the manufacturer's development department. Background Although production was decided based on "Formula A," the manufacturer later proposed an improved "Formula AB." However, since "Formula AB" showed crystallization in stability tests, both companies agreed again to produce with the original "Formula A" and the order was accepted. Due to a handover failure within the manufacturer's development department, the crystallization-risk "Formula AB" was communicated as the decided formula. Before production, when FATUITE Inc. reconfirmed "is it correct that you are using Formula A (the non-crystallizing one)?", the manufacturer responded "we are manufacturing with the non-crystallizing one" without verifying the actual situation. Because the manufacturer neglected to perform an "accelerated aging test" (a test to confirm stability by artificially accelerating normal use deterioration in a short period) immediately after bulk production, the product was shipped without detecting the possibility of crystallization. Crystallization was confirmed in an accelerated aging test on filled products conducted about one month later, leading to the current situation. These are all due to the manufacturer's internal communication and record-keeping failures, an issue of the manufacturer's internal control. FATUITE Inc. is in a position where they have no choice but to make judgments based on our reports, and this was an event that occurred beyond their scope of management. ③ Product Usability Regarding use before crystallization begins, no health damage has been reported at this time. After crystallization begins, the crystal particles may cause physical irritation when they come into contact with the skin. We ask customers who have the target product to refrain from using it, regardless of the presence of this phenomenon, and to cooperate with the return. ④ Future Actions In the future, we will thoroughly manage prototype quality confirmation results in the development department, confirm blending quantities before manufacturing, check manufacturing records, and strengthen the information sharing system among development staff to strive for recurrence prevention so that a similar situation does not happen again. We once again deeply apologize to our customers, FATUITE Inc., and all related parties for the great inconvenience and concern we have caused as the company responsible for manufacturing and sales. I.A.C. Inc. President Naohisa Okumura URL: https://www.cosmetics-iac.jp/