Why it was recalled
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Product description
NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), Mfd. for Healthway Corp. Comments or Questions NatraBio Shelburne Falls, MA 01370 USA, UPC 3 71400 55711 2
Lot numbers, UPCs & expiration codes
Lot: 222016, Exp: 01/25;
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-0438-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 23, 2023
- FDA report date
- Mar 15, 2023
- Quantity
- 4004
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nutraceutical Corporation
Original FDA data
Every field from FDA enforcement report D-0438-2023, 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: 222016, Exp: 01/25;
- Postal code
- 84098-6502
- Report date
- Mar 15, 2023
- Product type
- Drugs
- Recall number
- D-0438-2023
- Classification
- Class II
- Recalling firm
- Nutraceutical Corporation
- Product quantity
- 4004
- Reason for recall
- CGMP Deviations: Raw material recalled by repackager, due to discoloration.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), Mfd. for Healthway Corp. Comments or Questions NatraBio Shelburne Falls, MA 01370 USA, UPC 3 71400 55711 2
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Feb 23, 2023
- Initial firm notification
- Letter
- Center classification date
- Mar 7, 2023