WASHINGTON, D.C. — Federal health authorities with the U.S. Food and Drug Administration (FDA) cautioned the manufacturer of Rompe Pecho cough syrup that its product could be contaminated and potentially make people sick. Notwithstanding, that clear warning from the FDA, Efficient Laboratories delayed corrective measures for two months. According to an article appearing on Drugs.com, the FDA informed Efficient Laboratories about microbial contamination in three of the company’s Rompe Pecho cold and flu medications at the beginning of October 2019. Efficient Laboratories took no action until January 31, 2020, when Efficient Laboratories announced a recall of one lot of its medications. Rompe Pecho is available over-the-counter for people 6-years-of-age or older. Efficient Laboratories said it has not learned of any illnesses stemming from the consumption of its tainted medicine.
The FDA recommended to Efficient Laboratories that it should recall Rompe Pecho MAX, Rompe Pecho EX, and Rompe Pecho CF cough medications on October 9, 2019. The FDA did not expressly state the nature of the contamination other than to describe it as “microbial.” The FDA noted on its website that Efficient Laboratories had not taken any steps to commence a recall program.
The FDA allowed Efficient Laboratories to wait. The company finally announced a recall program for only one lot of each of its three cough syrups. Efficient Laboratories stated in a press release that consuming its Rompe Pecho cough syrup might give the patient vomiting and diarrhea. Efficient Laboratories did not specify a microbe that infected its cough syrup.
The recalled lots have expiry in 2022. Rompe Pecho MAX expires in February of 2022. Rompe Pecho CF expires in August of 2022. Rompe Pecho EX expires in June of 2022.
All consumers are advised to check the products they bought with the recall information. Efficient Laboratories cautioned consumers to stop taking the medication immediately. Consumers can return the cough syrup to the store of purchase.
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