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Recall Observatory FDA recall evidence

Drug product

Equi-Soft Foam, Antimicrobial Hand Soap, 0.55% Benzalkonium Chloride, 25 fl oz (750 mL), OTC, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102, NDC 47593-521-41

D-0274-2019

November 09, 2018

Class II

Product summary

Firm
Ecolab Inc
Event
Event 81510
Status
Terminated
Classification
Class II
Quantity
12,540 bottles
Official record key
drug-enforcement:D-0274-2019

Official wording

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

Code information: Lot# L062881, Exp 06/20, 5338HU1800, Exp 08/20

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label mix-up