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Recall Observatory FDA recall evidence

Drug product

Rompe Pecho CF Cold & Flu Advanced Formula, 6 Fl. oz. (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-235-06

D-0290-2022

August 24, 2021

Class II

Product summary

Firm
Efficient Laboratories, Inc.
Event
Event 89205
Status
Terminated
Classification
Class II
Quantity
10,833 bottles
Official record key
drug-enforcement:D-0290-2022

Official wording

Reason: Microbial Contamination of Non-Sterile Products

Code information: Lot #: 19F88 Exp. June 2022; 19G164 Exp. July 2022.

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial Contamination