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Safety Report: Rompe Pecho Liquid Cold and Flu - recalled due to microbial contamination, United States

2 years ago source fda.gov

Recall notice

United States

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 list below:

Rompe Pecho CF
Lots: 19F88 (Exp. Jun. 2022)
19G164 (Exp. Jul. 2022)

Rompe Pecho DM
Lots: 19F168 (Exp. Jun. 2022),
19G145 (Exp. Jul. 2022), 19G361 (Exp. Jul. 2022), 19G449 (Exp. Jul. 2022),
19G491 (Exp. Jul. 2022)

Rompe Pecho EX
Lots: 19H20 (Exp. Aug. 2022), 19J98 (Exp. Sep. 2022), 19A418 (Exp. Jan. 2022),
19E411 (Exp. May 2022)

Rompe Pecho MAX
Lot: 19G219 (Exp. Jul. 2022)

Company name: Efficient Laboratories, Inc
Brand name: Rompe Pecho
Product recalled: Liquid Cold and Flu symptom relief
Reason of the recall: Microbial contamination
FDA Recall date: December 10, 2021

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.

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/efficient-laboratories-inc-expands-voluntary-nationwide-recall-consumers-include-twelve-additional

Source: FDA

#drugs #recall #unitedstates

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