Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged in 0.22 Fl. oz. (6.6 mL) bottles, Mfg. for
Summary
The FDA issued a Class II for Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged in by Atlantic Management Resources Ltd.. Reason: cGMP Deviations.
Details
Source
Drug Recall
External ID
D-0081-2023
Action Date
2022-12-21
Status
Terminated
Category
drug
Product Description
Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged in 0.22 Fl. oz. (6.6 mL) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01.
Lot/Code Info: Lot Code B-02
Quantity Affected: 461 bottles
Reason for Recall
cGMP Deviations
Distribution
Nationwide and Australia
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-12
Company
Westborough, MA
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 29 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Atlantic Management Resources Ltd. has 5 FDA actions in our database, including 5 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 (Atlantic Management Resources Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Atlantic Management Resources Ltd. have FDA actions?
Atlantic Management Resources Ltd. has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0081-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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