FDA Recall D-0437-2023
Nutraceutical Corporation · Park City, UT
Class II Ongoing 1176 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
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
Reason for recall
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Recall record
- Recall number
D-0437-2023- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA.
- Recall initiated
- 2023-02-23
- Classified by FDA Center
- 2023-03-07
- FDA published
- 2023-03-15
- Recalling firm
- Nutraceutical Corporation
- Firm location
- Park City, UT
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.