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Efficient Laboratories, Inc. Expands Voluntary Recall to Consumers to Include 12 Additional Lots of Rompe Pecho CF, Rompe Pecho EX, Rompe Pecho MAX, and Rompe Pecho DM

Audience: Patient, Health Professional, Pharmacy

December 9, 2021 – Miami, Florida. Efficient Laboratories is expanding its voluntary nationwide recall to consumers to include an additional twelve lots of Rompe Pecho CF, Rompe Pecho EX, Rompe Pecho MAX, and Rompe Pecho DM due to microbial contamination concerns. These lots were distributed in 2019. To date, Efficient Laboratories has not received any reports of adverse events.

In rare circumstances, consumption of these specific lots could result in illness. 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 affected twelve lots of Rompe Pecho product are contained in the chart below:

The lot numbers and expiration dates can be found on the bottom of the cartons. These Rompe Pecho products were distributed nationwide to wholesalers and retailers.

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. 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.

Consumers with questions regarding this recall can contact Efficient Laboratories by phone at (305) 805-3456, Monday through Friday from 9 am to 4:30 pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse events or product complaints experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

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