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Recall Observatory FDA recall evidence

Drug product

Rompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166 UPC 0 00856 00309 5, NDC 58593-828-08

D-0293-2022

August 24, 2021

Class II

Product summary

Firm
Efficient Laboratories, Inc.
Event
Event 89205
Status
Terminated
Classification
Class II
Quantity
4,026 bottles
Official record key
drug-enforcement:D-0293-2022

Official wording

Reason: Microbial Contamination of Non-Sterile Products

Code information: Lot #: 19G219 Exp. July 2022

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial Contamination