Voluntary recall of certain batches of a topical lotion due to the detection of N-nitroso-diisopropanolamine
Product and Background
- The affected product is a 0.3% heparin-like lotion labeled “NIT,” used for improving blood flow and skin hydration.
- The company conducted testing and found levels of N-nitroso-diisopropanolamine above provisional daily limits.
- As a precaution, temporarily set management threshold was established at 2680ng/day.
- Products older than 25 months, especially those over 20 months, are being voluntarily recalled; newer stock is considered safe.
- The contamination likely results from interactions between the added diisopropanolamine and nitrites in raw materials.
Limit determination:
- The underlying acceptable daily intake for N-nitroso-diisopropanolamine is 400 ng/day, based on the European CPCA approach and assuming lifetime exposure of 70 years.
- Because this product was launched on June 14, 2024 and falls into an exposure period of more than one year rather than lifetime use, the company applied the ICH M7 Less-Than-Lifetime (LTL) approach.
- It multiplied 400 ng/day by 6.7 to establish the interim limit: 400 × 6.7 = 2,680 ng/day.
- The limit was agreed following consultation with Japan’s Ministry of Health, Labour and Welfare and is intended to apply until risk-control measures are implemented.