FDA Issues Highest Risk Level for Recalled Over-the-Counter Drug

A notice published by the Food and Drug Administration (FDA) labeled an ongoing recall of Gas-X as the most serious and urgent risk level due to contamination of the product.
In a notice published last week, the FDA said on June 17 it classified the recall of several lots of Gas-X, an over-the-counter anti-bloating medication, as Class I, or the most serious.
The reason for the Gas-X recall and classification, it said, is due to a “chemical contamination” caused by “diluted propylene glycol-based coolant from a machine leakage during the packaging process.”
“There is a potential that ingestion of the Softgels contaminated with the diluted propylene glycol-based coolant may result in adverse events such as nausea, vomiting, abdominal pain, and diarrhea,” a news release about the recall issued earlier this month said….