Why it was recalled
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Product description
NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula, 0.8 fl oz( 24mL), Mfd. Nutraceutical Corp., NaturalCare Park City, UT, 84098 USA, UPC 3 71400 70801 9
Lot numbers, UPCs & expiration codes
Lot: 221263, Exp: 10/24; 222047, 222048 Exp: 02/25; 222099, 222100, Exp: 03/25
Where it was sold
Nationwide in the USA.
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-0437-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 23, 2023
- FDA report date
- Mar 15, 2023
- Quantity
- 13,974
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nutraceutical Corporation
Original FDA data
Every field from FDA enforcement report D-0437-2023, exactly as published.
Show all FDA fields
- City
- Park City
- State
- UT
- Status
- Ongoing
- Country
- United States
- Event ID
- 91708
- Address
- 1777 Sun Peak Dr
- Code information
- Lot: 221263, Exp: 10/24; 222047, 222048 Exp: 02/25; 222099, 222100, Exp: 03/25
- Postal code
- 84098-6502
- Report date
- Mar 15, 2023
- Product type
- Drugs
- Recall number
- D-0437-2023
- Classification
- Class II
- Recalling firm
- Nutraceutical Corporation
- Product quantity
- 13,974
- Reason for recall
- CGMP Deviations: Raw material recalled by repackager, due to discoloration.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula, 0.8 fl oz( 24mL), Mfd. Nutraceutical Corp., NaturalCare Park City, UT, 84098 USA, UPC 3 71400 70801 9
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Feb 23, 2023
- Initial firm notification
- Letter
- Center classification date
- Mar 7, 2023