Why it was recalled
CGMP Deviations
Product description
Purely Soothing MSM Nasal Spray, 15%, packaged in 30ml, 1.014 fl. oz bottles, Manufactured by: Pharmedica USA, Phoenix, AZ, UPC 7 31034 91380 5
Lot numbers, UPCs & expiration codes
Lot #: 1808051, Exp.: 01/01/2027
Where it was sold
Nationwide in the USA and Worldwide through e-commerce and trade shows
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-0457-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 14, 2023
- FDA report date
- Mar 15, 2023
- Quantity
- 995 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmedica USA, LLC
Original FDA data
Every field from FDA enforcement report D-0457-2023, exactly as published.
Show all FDA fields
- City
- Phoenix
- State
- AZ
- Status
- Ongoing
- Country
- United States
- Event ID
- 91707
- Address
- 2836 W Deer Valley Rd Bldg E2
- Code information
- Lot #: 1808051, Exp.: 01/01/2027
- Postal code
- 85027-2300
- Report date
- Mar 15, 2023
- Product type
- Drugs
- Recall number
- D-0457-2023
- Classification
- Class II
- Recalling firm
- Pharmedica USA, LLC
- Product quantity
- 995 bottles
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Purely Soothing MSM Nasal Spray, 15%, packaged in 30ml, 1.014 fl. oz bottles, Manufactured by: Pharmedica USA, Phoenix, AZ, UPC 7 31034 91380 5
- Distribution pattern
- Nationwide in the USA and Worldwide through e-commerce and trade shows
- Recall initiation date
- Feb 14, 2023
- Initial firm notification
- Center classification date
- Mar 10, 2023