Sales of Medicube cream can resume, 2 batches found with minute amounts of prohibited ingredient will be recalled: HSA

The Health Sciences Authority (HSA) has lifted the suspension on sales of Medicube PDRN Pink Collagen Capsule Cream in Singapore, as two batches containing minute amounts of Sudan IV have been found to be clear of the prohibited ingredient. The two affected batches, identified as 2E122I.2E117I and 2E191G.2E193G, will be recalled and disposed of.

Previously, the HSA had directed three companies, APR SG Pte. Ltd., Rirora International Pte. Ltd., and Venus Beauty Pte. Ltd., to halt the sale of the product on July 31 for further testing. All current stock of the unaffected Medicube cream belongs to the batches previously cleared by the HSA. The regulator has now instructed all three companies to ensure all future batches of their Medicube PDRN Pink Collagen Capsule Cream products undergo testing for Sudan IV by an accredited laboratory before being sold locally.

This precautionary measure aims to prevent the recurrence of any issues. Sudan IV, a Sudan Red dye, is not permitted for use in cosmetic products in Singapore. While the minute levels detected in the recalled batches are deemed unlikely to cause serious health risks, the HSA advises consumers to discontinue using the affected products.

Consumers with refund concerns should reach out to the respective sellers. No local adverse events have been reported so far. Additionally, the HSA warns consumers against purchasing cosmetics from unverified sources, emphasizing the importance of buying from reputable retailers in Singapore to ensure product safety. Cosmetic product notification under the Health Products (Cosmetic Products – ASEAN Cosmetic Directive) Regulations 2007 is mandatory for dealers before a product can be marketed, but it does not constitute premarket approval or certification.

Dealers must comply with regulatory requirements, including the prohibition and restriction of certain ingredients and proper product labeling. Failure to do so may result in enforcement actions, including penalties of up to S$50,000 and/or imprisonment for up to two years.