FDA Warns of Cough Syrup Contamination

October 14, 2019

Consumers should stop use and report any adverse events.

The FDA has issued a warning to consumers regarding the use of Rompe Pecho EX and Rompe Pecho CF cough syrups.

According to a drug safety communication issued by the agency, the cough syrups for children six years of age and older may have become microbially contaminated at its manufacturing facility, Efficient Laboratories, Inc. At the time of this release, the FDA says they are not aware of any adverse events with these particular medicines. 

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Consumers are advised to suspend use and dispose of the medications; Efficient Laboratories has also received a recommendation from the FDA to voluntarily recall the products. 

Patients can report any adverse events and/or quality problems to MedWatch’s 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