OTC Cold & Flu Meds Recalled

Citing microbial contamination concerns, Efficient Laboratories is voluntarily recalling several lots of the over-the-counter medications Rompe Pecho CF, Rompe Pecho EX, Rompe Pecho MAX, and Rompe Pecho DM, according to the December 29, 2021, US Food and Drug Administration (FDA) Enforcement Report.

“In rare circumstances, consumption of these specific lots could result in illness,” the company advised in a December 10, 2021, statement. “These products are used to treat symptoms of the flu and the common cold, and each are packaged in a box containing a bottle of the liquid product.”

The recall includes the following products and lots, which were distributed by Efficient Laboratories throughout the United States:

• Rompe Pecho CF Cold & Flu, 6 fl. oz. (178 mL; NDC 58593-235-06), from lots 19F88 (Exp. 6/22) and 19G164 (Exp. 7/22);
• Rompe Pecho EX Expectorant, 4 fl. oz. (118 mL; NDC 58593-829-04), from lots 19H20 (Exp. 8/22), 19A418 (Exp. 1/22), and 19E411 (Exp. 5/22);
• Rompe Pecho EX Expectorant, 6 fl. oz. (178 mL; NDC 58593-829-06), from lots 19H20 (Exp. 8/22), 19J98 (Exp. 9/22), 19A418 (Exp. 1/22), and 19E411 (Exp. 5/22);
• Rompe Pecho MAX Multi Symptoms, 8 fl. oz. (237 mL; NDC 58593-828-08), from lot 19G219 (Exp. 7/22); and
• Rompe Pecho DM, 6 fl. oz. (178 mL; NDC 58593-275-06), from lots 19F168 (Exp. 6/22), 19G145 (Exp. 7/22), 19G361 (Exp. 7/22), 19G449 (Exp. 7/22), and 19G491 (Exp. 7/22).

Efficient Laboratories initiated the recall August 24, 2021. The FDA designated the recall Class II on December 22, 2021, communicating that use of the medication may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

“Consumers that have Rompe Pecho EX, Rompe Pecho CF, Rompe Pecho DM, or Rompe Pecho MAX from these lots that are being recalled should stop using these products and discard them,” the company stated. “Efficient Laboratories has notified its distributors of these lots. All distributors have confirmed there is no product in their inventory. In addition, a review of certain stores confirmed no inventory at the retail level as well.”