Why it was recalled
CGMP DEVIATIONS
Product description
Nose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin), packaged in 0.46 oz. (13g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756
Lot numbers, UPCs & expiration codes
Lot #: 1E253A, Exp. Date AUG-2024
Where it was sold
Nationwide within the United States
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-0450-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 24, 2023
- FDA report date
- Mar 15, 2023
- Quantity
- 37,968 metal tube/folding carton
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ecometics, Inc.
Original FDA data
Every field from FDA enforcement report D-0450-2023, exactly as published.
Show all FDA fields
- City
- Norwalk
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 91719
- Address
- 19 Concord St
- Code information
- Lot #: 1E253A, Exp. Date AUG-2024
- Postal code
- 06854-3706
- Report date
- Mar 15, 2023
- Product type
- Drugs
- Recall number
- D-0450-2023
- Classification
- Class II
- Recalling firm
- Ecometics, Inc.
- Product quantity
- 37,968 metal tube/folding carton
- Termination date
- Jun 21, 2023
- Reason for recall
- CGMP DEVIATIONS
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Nose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin), packaged in 0.46 oz. (13g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Feb 24, 2023
- Initial firm notification
- Letter
- Center classification date
- Mar 8, 2023