Recalls / Class III
Class IIID-1541-2020
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
- Brand name
- Red Cross Oral Pain Relief
- Generic name
- Benzocaine
- Active ingredient
- Benzocaine
- Route
- Topical
- NDC
- 10742-8902
- FDA application
- M022
- Affected lot / code info
- Item Number: 95090007 Lot #: 66572
Why it was recalled
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.
Recalling firm
- Firm
- The Mentholatum Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 707 Sterling Dr, N/A, Orchard Park, New York 14127-1557
Distribution
- Quantity
- 31,732 Blister Packs
- Distribution pattern
- Nationwide within the U.S.
Timeline
- Recall initiated
- 2020-07-31
- FDA classified
- 2020-08-24
- Posted by FDA
- 2020-09-02
- Terminated
- 2022-05-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1541-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.