May 2019 FDA Recall Quik-care by Ecolab Inc
D-1393-2019 - Incorrect/undeclared excipients

This Class III drug recall was voluntarily initiated by Ecolab Inc on May 10, 2019 for the product Quik-care. The FDA reported the reason for recall as incorrect/undeclared excipients. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1393-2019

Reason for Recall
Incorrect/undeclared excipients: Hand sanitizer was made using the wrong alcohol raw material.
Initiated
05-10-2019
Reported
06-26-2019
Quantity
183 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83114
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-17-2022
Product Description About Product Description
Full technical description of the product.
QUIK-CARE Aerosol Foam Hand Sanitizer (62.5% Ethyl Alcohol), packaged in 7 oz cans, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102-1390 USA, NDC 47593-490-82

Batch or Lot Expiration Information

Lot# : C040591, Exp 4/21

Affected Packages Involved in this Recall

47593-490-82 Quik-care
47593-490-87 Quik-care