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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
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TOPIC: Twelve Additional Lots of Rompe Pecho Products Sold in 2019 by Efficient Laboratories: Recall Expansion - Due to Microbial Contamination Concerns
AUDIENCE: Patient, Health Professional, Pharmacy
ISSUE: Efficient Laboratories is expanding its recall 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. The affected lots were distributed in 2019.
In rare circumstances, consumption of these specific lots could result in illness.
To date, Efficient Laboratories has not received any reports of adverse events.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The products being recalled are used to treat symptoms of the flu and the common cold.
RECOMMENDATIONS:
- Consumers that have Rompe Pecho EX, Rompe Pecho CF, Rompe Pecho DM, or Rompe Pecho MAX from the lots that are being recalled should stop using these products and discard them.
- 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.
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Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
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Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
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