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Drug FDA Class II Ongoing cGMP deviation

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

Atlantic Management Resources Ltd. Published Sep 17, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 50/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Atlantic Management Resources Ltd. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

cGMP violations

Affected products (1)

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

72 containers

Lot codes: B-02
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)

Affected areas

Product was distributed via the internet.

Timeline

  1. Initiated
    Aug 27, 2025
  2. Published
    Sep 17, 2025
Recall number
D-0629-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.