FDA Recall D-0457-2023
Pharmedica USA, LLC · Phoenix, AZ
Class II Ongoing 1185 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
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
Reason for recall
CGMP Deviations
Recall record
- Recall number
D-0457-2023- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide in the USA and Worldwide through e-commerce and trade shows
- Recall initiated
- 2023-02-14
- Classified by FDA Center
- 2023-03-10
- FDA published
- 2023-03-15
- Recalling firm
- Pharmedica USA, LLC
- Firm location
- Phoenix, AZ
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.