July 2020 FDA Recall Red Cross Oral Pain Relief by The Mentholatum Company
D-1541-2020 - Labeling; Not Elsewhere Classified

This Class III drug recall was voluntarily initiated by The Mentholatum Company on July 31, 2020 for the product Red Cross Oral Pain Relief. The FDA reported the reason for recall as labeling; not elsewhere classified. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1541-2020

Reason for Recall
Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the labeling of the cotton pellet box found within the Red Cross Oral Pain blister pack. The cotton pellet box states that the product contains "Natural Eugenol Oil" in which it does not.
Initiated
07-31-2020
Reported
09-02-2020
Quantity
31,732 Blister Packs

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86154
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.
The Mentholatum Company
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.
Nationwide within the U.S.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-20-2022
Product Description About Product Description
Full technical description of the product.
Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 Fl. Oz. (3.7 mL) bottle with Cotton Pellets box packaged in a blister pack, Distributed by: Mentholatum Company, Orchard Park, NY 14127 NDC 10742-8902-1, UPC 3 10742 09509 8

Batch or Lot Expiration Information

Lot# Item Number: 95090007
Lot# : 66572

Affected Packages Involved in this Recall

10742-8902-1 Red Cross Oral Pain Relief