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  1. Drug Safety and Availability

FDA advises consumers not to use Rompe Pecho cough syrup

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[10/11/2019] FDA advises consumers not to use Rompe Pecho EX and Rompe Pecho CF cough syrups distributed by Efficient Laboratories, Inc., Miami, Florida, due to microbial contamination risks. These are over-the-counter medicines for children six years and older. FDA recommends consumers stop using these medicines and dispose of them. These contaminated cough medicines could potentially cause illness.

On October 9, 2019, FDA recommended that Efficient Laboratories recall Rompe Pecho EX and Rompe Pecho CF cough syrups. To date, the company has not taken action to remove these potentially dangerous medicines from the market.

FDA is not aware of any reports of adverse events associated with these medicines at this time. Consumers who use Rompe Pecho EX and Rompe Pecho CF cough syrups and have concerns should contact their health care professional.

FDA encourages health care professionals and patients to report adverse events or quality problems experienced with the use of any medication to FDA’s MedWatch Adverse Event Reporting program: 

  • Complete and submit the report online; or
  • Download and complete the form, then submit it via fax at 1-800-FDA-0178