Gas-X
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Class I — High risk. Reasonable probability of serious harm or death.
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Cause type: Chemical / undeclared
A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.
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.
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton
Microbial Contamination of Non-Sterile Products
Chemical contamination; presence of lead and lithium above specification
Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.
Chemical contamination: Presence of benzene
Chemical contamination: Presence of benzene
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