Haleon US Holdings LLC — Class I: Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674
Haleon US Holdings LLC has initiated a Class I recall of Gas-X Extra Strength (Simethicone 125 mg) softgels due to chemical contamination from a diluted propylene glycol-based coolant that leaked from machinery during the packaging process.
This affects Haleon US Holdings LLC, distributors of Gas-X Extra Strength softgels, and QA/Manufacturing teams responsible for oversight of packaging line integrity.
A Class I designation indicates the FDA's assessment of a reasonable probability that exposure to the product will cause serious adverse health consequences or death. This event highlights a critical failure in equipment maintenance and containment, suggesting that leaks in secondary or tertiary packaging stages can lead to high-severity regulatory actions if they compromise the primary container or product.
Quality units should review equipment maintenance logs and leak detection protocols for packaging machinery. Ensure that CAPA processes specifically address the risk of incidental contact with non-food-grade or diluted lubricants/coolants during the finishing stages of production.
Class I. Reason: Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.. Product: Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059.. Firm: Haleon US Holdings LLC (Warren NJ United States). Status: Ongoing.
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