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Recall Observatory FDA recall evidence

Drug product

Medi-Stat Foam, Antimicrobial Hand Soap, Chloroxylenol 0.5%, 1250 mL (42.3 fl oz), OTC, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102, NDC 47593-503-59

D-0275-2019

November 09, 2018

Class II

Product summary

Firm
Ecolab Inc
Event
Event 81510
Status
Terminated
Classification
Class II
Quantity
14,108 bottles
Official record key
drug-enforcement:D-0275-2019

Official wording

Reason: Labeling: Label mix-up - the label on the product may not match the formula in the bottle.

Code information: Lot#: L062281, Exp 06/20

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label mix-up