Home / Recalls / The Mentholatum Company / D-1541-2020

D-1541-2020 Class III Terminated

Recalled by The Mentholatum Company — Orchard Park, NY

Recall Details

Product Type
Drugs
Report Date
September 2, 2020
Initiation Date
July 31, 2020
Termination Date
May 20, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
31,732 Blister Packs

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

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.

Distribution Pattern

Nationwide within the U.S.

Code Information

Item Number: 95090007 Lot #: 66572

Other recalls by The Mentholatum Company

  • D-0018-2016 Class II — WellPatch¿ Capsaicin Pain Relief Patch, 0.025% Natural Capsaicin, External Analg (September 17, 2015)
  • D-1040-2014 Class II — ROHTO Cooling Eye Drops, Itch Relief, Soothes Itch & Burn, relief, Astringent, L (January 16, 2014)
  • D-1038-2014 Class II — ROHTO Redness Relief, ice, Redness Reliever, Lubricant, Astringent Eye Drops, St (January 16, 2014)
  • D-1037-2014 Class II — ROHTO Redness Relief, arctic, Redness Reliever, Lubricant Eye Drops, Sterile, Ne (January 16, 2014)
  • D-1041-2014 Class II — ROHTO Redness Relief, Cool, Redness Reliever, Lubricant Eye Drops, Sterile, Net. (January 16, 2014)
  • D-1039-2014 Class II — ROHTO Dry Eye, hydra, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). (January 16, 2014)