October 2015 FDA Recall Drug by Steris Corp
D-0518-2016 - Labeling

This Class II drug recall was voluntarily initiated by Steris Corp on October 27, 2015 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in Medical Center/Hospitals in FL, MO, and TN. and the recall is currently terminated.

Recall Number: D-0518-2016

Reason for Recall
Labeling: Not Elsewhere Classified; Incorrect/Undeclared Excipients: Outdated previous version of label applied to products that incorrectly states one inactive ingredient.
Initiated
10-27-2015
Reported
12-16-2015
Quantity
3 cases - 54 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72479
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.
Steris Corp
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.
Medical Center/Hospitals in FL, MO, and TN.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-07-2016
Product Description About Product Description
Full technical description of the product.
Kindest Kare Antimicrobial Foaming Handwash, Hand Soap, 0.75% Triclosan, 444 ml (15 fl oz) bottles, STERIS Corporation, 7501 Page Avenue, St. Louis, MO 63133, Reorder # 1452-RF, NDC 0519-1452-13, UPC (01)00724995 086251.

Batch or Lot Expiration Information

Lot# 277120, Exp 06/01/17