Red Cross Oral Pain Relief Liquid
FDA Recall NDC 10742-8902
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Red Cross Oral Pain Relief (NDC 10742-8902). A significant event, classified as Class III, was initiated on Jul 31, 2020 by The Mentholatum Company. The reported reason for this action was: "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."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
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.
Jul 31, 2020
Sep 02, 2020
31,732 Blister Packs
Recall Profile & Regulatory Data
Event ID
86154
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
The Mentholatum Company
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the U.S.
Termination Date
May 20, 2022
Product Description
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
10742-8902-1Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
