NaturalCare, children's, Allergy Care, Homeopathic, 4 Months and Up, Liquid Drops, 0.1% Alcohol, 1 FL OZ( 30mL), Mfd. Nu
Summary
The FDA issued a Class II for NaturalCare, children's, Allergy Care, Homeopathic, 4 Months and Up, Liquid Drop by Nutraceutical Corporation. Reason: CGMP Deviations: Raw material recalled by repackager, due to discoloration..
Details
Source
Drug Recall
External ID
D-0440-2023
Action Date
2023-03-15
Status
Ongoing
Category
drug
Product Description
NaturalCare, children's, Allergy Care, Homeopathic, 4 Months and Up, Liquid Drops, 0.1% Alcohol, 1 FL OZ( 30mL), Mfd. Nutraceutical Corp., Salt Lake City, UT, 84101 USA, UPC 3 71402 30101 0
Lot/Code Info: Lot 222148, Exp: 05/25;
Quantity Affected: 1590
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-0440-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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