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Recall Observatory FDA recall evidence

Drug 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

D-1541-2020

July 31, 2020

Class III

Product summary

Firm
The Mentholatum Company
Event
Event 86154
Status
Terminated
Classification
Class III
Quantity
31,732 Blister Packs
Official record key
drug-enforcement:D-1541-2020

Official wording

Reason: 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.

Code information: Item Number: 95090007 Lot #: 66572

Distribution pattern: Nationwide within the U.S.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.