July 2020 FDA Recall Drug by Ecolab Inc
D-1539-2020 - Discoloration and Presence of Foreign Substance

This Class II drug recall was voluntarily initiated by Ecolab Inc on July 30, 2020 for the product Drug. The FDA reported the reason for recall as discoloration and presence of foreign substance. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1539-2020

Reason for Recall
Discoloration and Presence of Foreign Substance
Initiated
07-30-2020
Reported
09-02-2020
Quantity
305 drums

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86246
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2023
Product Description About Product Description
Full technical description of the product.
Hand Sanitizer (Alcohol 80% v/v) topical solution, 55 US GAL (208 L) EcoLab Inc 1 EcoLab Place St. Paul, MN 55102 USA, NDC 47593-624-21

Batch or Lot Expiration Information

Lot# : BP0D3091A0, BP0D3203A0, CR0D0553A0, CR0D0571A0, CR0D0577A0, CR0D0584A0, CR0E0482A0, CR0E0490A0, CR0E0499A0, CR0E0501A0, CR0E0520A0, FO0D0358A0, FO0D0440A0, FO0D0456A0, FO0D0464A0, FO0D0480A1, FO0D0490A0, FO0D0502A1, FO0D0517A1, FO0E0044A1, FO0E0061A1, FO0E0075A1, FO0E0094A0, FO0E0111A0, FO0E0119A1, FO0E0241A1, FO0E0256A1; Exp. Date April 2021