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Recall Observatory FDA recall evidence

Drug product

New! Rompe Pecho MAX Multi Symptoms, 8 FL. Oz (237 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 00309 5

D-0847-2020

January 31, 2020

Class II

Product summary

Firm
Efficient Laboratories, Inc.
Event
Event 84864
Status
Terminated
Classification
Class II
Quantity
4080 8 FL Oz bottles
Official record key
drug-enforcement:D-0847-2020

Official wording

Reason: Microbial Contamination of Non-Sterile Products

Code information: Lot: 19B42 Exp. February 2022

Distribution pattern: Distributed Nationwide in the USA

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial Contamination