Multi-event November 2018 FDA Recall Ecolab Inc. by Ecolab Inc
This Multi-event Class II drug recall was voluntarily initiated by Ecolab Inc on November 9, 2018 for the product Ecolab Inc.. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0275-2019
Labeling: Label mix-up - the label on the product may not match the formula in the bottle.
11-09-2018
11-28-2018
14,108 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Ecolab Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S.A. Nationwide
11-06-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : L062281, Exp 06/20
Affected Packages Involved in this Recall
Recall Number: D-0274-2019
Labeling: Label mix-up - the label on the product may not match the formula in the bottle.
11-09-2018
11-28-2018
12,540 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Ecolab Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S.A. Nationwide
11-06-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# L062881, Exp 06/20, 5338HU1800, Exp 08/20
