Drug 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.
D-0595-2026
Product summary
- Event
- Event 99125
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 35,883 boxes/carton
- Official record key
drug-enforcement:D-0595-2026
Official wording
Reason: Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Code information: Lots: a) TL8K, YH9X, YH9Y, Exp. Date. 30Nov2028; b) X78N, Exp. Date 30Nov2028.
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination