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Recall Observatory FDA recall evidence

Drug product

Entertainer's Secret Throat Relief, 2.0 FL oz (59.2 mL), Honey Apple Flavor, KLI Corp, Carmel, IN

D-0328-2015

December 17, 2014

Class II

Product summary

Firm
Tropichem Research Labs, Inc.
Event
Event 70084
Status
Terminated
Classification
Class II
Quantity
24,348 / 2 oz. bottles
Official record key
drug-enforcement:D-0328-2015

Official wording

Reason: Microbial Contamination of Non Sterile Product; microbial assay reported unacceptable high plate counts and positive for E. Coli

Code information: Lot No. 141010, Best By Date: 10/2016; UPC Code: 728409847025

Distribution pattern: NY and IN.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial Contamination