Rompe Pecho Cold Remedy Products [US]:


US FlagUS/Silver Spring: Rompe Pecho Cold Remedy Recall [US]Efficient Laboratories, a Miami, Florida establishment, recalls certain batch/lots of Rompe Pecho CF, Rompe Pecho EX, Rompe Pecho MAX and Rompe Pecho DM Cold Remedy drug products from the American marketplace due to suspected unspecified microbial contamination and consequential risks of Gram-positive or Gram-negative bacterial infection, severe illness and/or possible life-changing complications, all serious health and safety hazards requiring immediate medical intervention to minimize pain and suffering as well as prevent life-altering injury or death.

FDA: http://ht.ly/buRb30s3NRf

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/efficient-laboratories-inc-expands-voluntary-nationwide-recall-consumers-include-twelve-additional

Additional information:
The US Food and Drug Administration (“FDA”) reports the following over-the-counter (“OTC”) Cold Remedy drugs are subject to this recall:

  • Rompe Pecho CF Cold Remedy, sold with a batch/Lot of 19F88 and an expiry date of June 2022
  • Rompe Pecho CF Cold Remedy, sold with a batch/Lot of 19G164 and an expiry date of July 2022
  • Rompe Pecho DM Cold Remedy, sold with a batch/Lot of 19F168 and an expiry date of June 2022
  • Rompe Pecho DM Cold Remedy, sold with a batch/Lot of 19G164 and an expiry date of July 2022
  • Rompe Pecho DM Cold Remedy, sold with a batch/Lot of 19G145 and an expiry date of July 2022
  • Rompe Pecho DM Cold Remedy, sold with a batch/Lot of 19G361 and an expiry date of July 2022
  • Rompe Pecho DM Cold Remedy, sold with a batch/Lot of 19G449 and an expiry date of July 2022
  • Rompe Pecho DM Cold Remedy, sold with a batch/Lot of 19G491 and an expiry date of July 2022
  • Rompe Pecho EX Cold Remedy, sold with a batch/Lot of 19H20 and an expiry date of August 2022
  • Rompe Pecho EX Cold Remedy, sold with a batch/Lot of 19J98 and an expiry date of September 2022
  • Rompe Pecho EX Cold Remedy, sold with a batch/Lot of 19A418 and an expiry date of January 2022
  • Rompe Pecho EX Cold Remedy, sold with a batch/Lot of 19E411 and an expiry date of May 2022
  • Rompe Pecho MAX Cold Remedy, sold with a batch/Lot of 19G219 and an expiry date of July 2022

Please consult the photograph above for details of the food’s packaging, design and retail presentation. Additional images of the recalled Code Remedy drugs can be found on the Web site above.

==> No barcodes, UPCs, NDCs, DINs, item numbers, best-before date codes, manufacturing date codes, production dates, expiry dates, regulatory approval designations, registration numbers, agency approval designations or other identification numbers were listed with this recall notification.

These Rompe Pecho CF, Rompe Pecho EX, Rompe Pecho MAX and Rompe Pecho DM Cold Remedy products were known to be marketed, distributed and sold in all US states although it is always possible these food products had wider distribution within the country. When in doubt, please contact the manufacturer for specific product information.

According to the FDA, Efficient Laboratories has recalled certain batch/lots of Rompe Pecho CF, Rompe Pecho EX, Rompe Pecho MAX and Rompe Pecho DM Cold Remedy products from the American marketplace due to suspected unspecified microbial contamination. As a result of this reported defect, you should neither serve nor consume the recalled drugs identified above.

==> For information about possible Staphylococcus or Streptococcus contamination, please consult the “Illnesses” tab on this site, located at the top of this page.

Proposed Remedy:
If you believe you have purchased or have in your possession any of the recalled Cold Remedy drugs, please do not consume them. Instead, return the retailer or online outlet to the store where you purchased it for a full refund.

Disposal of this product must be in accordance with local municipal hazardous waste requirements to protect the drinking water supply and the ecosystem. Do not dispose of this product through your household sewer system. Instead, consult with your local pharmacist or municipal waste authority for disposal instructions.

==> If you have a medical emergency, please contact 9-1-1, your closest hospital or emergency center equipped to properly treat bacterial poisonings.

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US Centers for Disease Control and Prevention Coronavirus Tips___________________________________________________________

If you have any further questions, comments or complaints about this recall, please contact Efficient Laboratories at +1-305-805-3456 during normal business hours Eastern Standard Time, Monday to Friday

==> To see other recalls and notifications caused by suspected contaminated, adulterated or mislabeled Cold Remedy products, please search for “cold remedy” or more generically, “drugs” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by suspected generic Bacterial contamination, please search for “bacterial” using the Search Box at the top of this page.

==> For information about possible Staphylococcus contamination, please consult the “Staphylococcus” tab on this site, located at the top of this page.

==> For information about possible Streptococcus contamination, please consult the “Streptococcus” tab on this site, located at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by Efficient Laboratories, please search for “Efficient” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold under the Rompe Pecho brand, please search for “Rompe Pecho” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 15254-2021
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
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General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
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Visit the Living Safely site:
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Report an unsafe food or drug you purchased in the US [external: new window opens]:
==> http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm
Search for a recalled food or drug on the US FDA Web archive [external: new window opens]:
==> http://www.fda.gov/Safety/Recalls/ArchiveRecalls/default.htm

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