Drug product
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
D-0542-2026
Product summary
- Event
- Event 98910
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 285,330 blister cards
- Official record key
drug-enforcement:D-0542-2026
Official wording
Reason: Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Code information: Lot: KB5Y, Expires: 04/2028; MP4B, Expires: 05/2028; SS4F, Expires: 09/2028.
Distribution pattern: U.S. Nationwide.
Derived failure modes
-
Labeling or packaging
Labeling: Not Elsewhere Classified- Incomplete