NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula, 0.8 fl oz( 24mL), Mfd. Nutraceutical Corp.,
Summary
The FDA issued a Class II for NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula, 0.8 by Nutraceutical Corporation. Reason: CGMP Deviations: Raw material recalled by repackager, due to discoloration..
Details
Source
Drug Recall
External ID
D-0437-2023
Action Date
2023-03-15
Status
Ongoing
Category
drug
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/Code Info: Lot: 221263, Exp: 10/24; 222047, 222048 Exp: 02/25; 222099, 222100, Exp: 03/25
Quantity Affected: 13,974
Reason for Recall
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Distribution
Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-23
Company
Park City, UT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 126 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Nutraceutical Corporation has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Nutraceutical Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Nutraceutical Corporation have FDA actions?
Nutraceutical Corporation has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0437-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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