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.
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
Lot numbers, UPCs & expiration codes
Item Number: 95090007 Lot #: 66572
Where it was sold
Nationwide within the U.S.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1541-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 31, 2020
- FDA report date
- Sep 2, 2020
- Quantity
- 31,732 Blister Packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Mentholatum Company
Original FDA data
Every field from FDA enforcement report D-1541-2020, exactly as published.
Show all FDA fields
- City
- Orchard Park
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 86154
- Address
- 707 Sterling Dr
- Code information
- Item Number: 95090007 Lot #: 66572
- Postal code
- 14127-1557
- Report date
- Sep 2, 2020
- Product type
- Drugs
- Recall number
- D-1541-2020
- Classification
- Class III
- Recalling firm
- The Mentholatum Company
- Product quantity
- 31,732 Blister Packs
- Termination date
- May 20, 2022
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide within the U.S.
- Recall initiation date
- Jul 31, 2020
- Initial firm notification
- Letter
- Center classification date
- Aug 24, 2020