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FDA consumer advisory says this children’s cough syrup has a microbial contamination risk

The FDA issued a consumer advisory earlier this month to avoid Rompe Pecho EX and Rompe Pecho CF children’s cough syrups for the possibility of a microbial contamination.

“These contaminated cough medicines could potentially cause illness,” the advisory says.

Though the advisory was first posted Oct. 11, it undoubtedly will get more attention now that Walmart noted the advisory on its food, drug and product recalls page.

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The advisory also says the FDA recommended the distributor, Northwest Miami-Dade company Efficient Laboratories, recall the cough syrups. Efficient hasn’t done so.

In response to questions from the Miami Herald, Efficient emailed a statement Tuesday afternoon that the company follows strict guidelines, hasn’t had a problem with the FDA in 36 previous years and “is currently working with the FDA to ensure the compliance of its products Rompe Pecho EX and Rompe Pecho CF.”

Not answered in the statement were questions from the Herald , such as, “Why has Efficient not recalled the cough syrups?” and “Where are the cough syrups manufactured and who is the manufacturer?”

An FDA spokesman said the agency discovered the risk during a recent inspection of the facility. Yet, the taxpayer-funded agency said federal law and FDA regulations prevented it from telling the public where the facility is or who runs the facility.

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Since 1989, David J. Neal’s domain at the Miami Herald has expanded to include writing about Panthers (NHL and FIU), Dolphins, old school animation, food safety, fraud, naughty lawyers, bad doctors and all manner of breaking news. He drinks coladas whole. He does not work Indianapolis 500 Race Day.
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