Cold and Flu Med Recalled Over Microbial Contamination

February 5, 2020

Efficient Laboratories, Inc. is voluntarily recalling 1 lot each of Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAXliquid products due to microbial contamination.

Efficient Laboratories, Inc. is voluntarily recalling 1 lot each of Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAX liquid products due to microbial contamination. The OTC meds are recommended for children 6 years and older.

“In rare circumstances, consumption of Rompe Pecho from these lots could result in vomiting and diarrhea,” the manufacturer said in a press release.1

However, Efficient Laboratories has not received any reports of adverse events to date.

Three lots contain microbial contamination: Rompe Pecho EX lot 19F332, expiration June 2022; Rompe Pecho CF lot 19H359, expiration August 2022; and Rompe Pecho MAX lot 19B42, expiration February 2022.1

They were distributed nationwide to wholesalers and retailers. These products, packaged in a box containing a bottle of the liquid product, are used to treat symptoms of the flu and the common cold.

Efficient Laboratories is notifying its distributors of these the recalled lots by email and is arranging for the return or replacement of all recalled products.

Consumers that have Rompe Pecho EX, Rompe Pecho CF, or Rompe Pecho MAX from the lots that are being recalled should stop using these products and discard or return them to the place of purchase, Efficient Laboratories said.1

In October 2019, FDA also advised consumers not to use Rompe Pecho EX and Rompe Pecho CF due to microbial contamination risks. “FDA recommends consumers stop using these medicines and dispose of them. These contaminated cough medicines could potentially cause illness,” the agency said in a press release.2

Even though the FDA recommended that Efficient Laboratories recall Rompe Pecho EX and Rompe Pecho CF cough syrups in early October, “the company has not taken action to remove these potentially dangerous medicines from the market,” the FDA said.2

FDA was not aware of any reports of adverse events associated with the cold and flu medicines at the time.

References:

 1. Efficient Laboratories Inc. Issues Voluntary Nationwide Recall of Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAX due to Microbial Contamination [company announcement]. FDA’s website. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/efficient-laboratories-inc-issues-voluntary-nationwide-recall-rompe-pecho-ex-rompe-pecho-cf-and

2. FDA advises consumers not to use Rompe Pecho cough syrup [news release]. FDA’s website. https://www.fda.gov/drugs/drug-safety-and-availability/fda-advises-consumers-not-use-rompe-pecho-cough-syrup.