Neuroquell & Neuroquell Plus, .22 fl. Oz (6.6mL),Mfg. For/Dist. By Claire Ellen Products, P.O. Box 901 Westboro, MA 0158
Summary
The FDA issued a Class II for Neuroquell & Neuroquell Plus, .22 fl. Oz (6.6mL),Mfg. For/Dist. By Claire Ellen by Atlantic Management Resources Ltd.. Reason: cGMP violations.
Details
Source
Drug Recall
External ID
D-0629-2025
Action Date
2025-09-17
Status
Ongoing
Category
drug
Product Description
Neuroquell & Neuroquell Plus, .22 fl. Oz (6.6mL),Mfg. For/Dist. By Claire Ellen Products, P.O. Box 901 Westboro, MA 01581 USA, NDC 66233712-01
Lot/Code Info: Lot # B-02 Batch #: 1087920520 Product # R937 BBE#31-05-21( May 31, 2021) Batch # 1087920920 Product # R937 BBE# 31-05-21 (May 31, 2021)
Quantity Affected: 72 containers
Reason for Recall
cGMP violations
Distribution
Product was distributed via the internet.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-27
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 68 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-0629-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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