November 2016 FDA Recall Drug by Les Emballages Knowlton Inc.
D-0225-2017 - Labeling

This Class III drug recall was voluntarily initiated by Les Emballages Knowlton Inc. on November 22, 2016 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0225-2017

Reason for Recall
Labeling: Label Mix Up- Incorrect back label applied to the product.
Initiated
11-22-2016
Reported
12-28-2016
Quantity
1,964 cases (35,352 cannisters)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75791
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.
Les Emballages Knowlton 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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-16-2017
Product Description About Product Description
Full technical description of the product.
Toms of Maine Naturally Dry Natural Powder Antiperspirant Stick, Distributed by: Tom's of Maine, Kennebunk, ME 04043, Made in Canada, Unit UPC: 077326831953 Case UPC: 10077326831950

Batch or Lot Expiration Information

Lot# Lot: 6282CA3818 Exp: 10/18