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Earwax Drops Recalled Nationwide for Weak Potency
19 Jul
Summary
- 11 peroxide products recalled for low active ingredient levels.
- Product assay significantly reduced to about 0.6% from 6.5%.
- Recall classified as Class II, indicating reversible health effects.
The U.S. Food and Drug Administration (FDA) announced on June 25 the withdrawal of 11 peroxide products from the market. This recall, distributed nationwide, addresses concerns over significantly reduced levels of the active ingredient, carbamide peroxide.
A report from July 14 indicated that approximately 244,432 containers of 6.5% carbamide peroxide were affected. Testing revealed an assay of around 0.6%, far below the expected concentration, suggesting the product may be ineffective for softening earwax as intended. The recalled units were available in 0.5-ounce sizes and bottle packaging.
The FDA has classified this as a Class II recall. This designation implies that exposure to the recalled products may cause temporary or medically reversible adverse health consequences. The probability of serious adverse health consequences is considered remote. This recall coincides with elevated national levels of respiratory viruses like rhinovirus and parainfluenza, according to July 10 data from the CDC.
