August 2025 FDA Recall Drug by Atlantic Management Resources Ltd.
D-0629-2025 - cGMP violations

This Class II drug recall was voluntarily initiated by Atlantic Management Resources Ltd. on August 27, 2025 for the product Drug. The FDA reported the reason for recall as cgmp violations. The product was distributed in Product was distributed via the internet. and the recall is currently ongoing.

Recall Number: D-0629-2025

Reason for Recall
cGMP violations
Initiated
08-27-2025
Reported
09-17-2025
Quantity
72 containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
97345
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Atlantic Management Resources Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed via the internet.
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# B-02
Lot# : 1087920520 Product # R937 BBE#31-05-21( May 31, 2021)
Lot# 1087920920 Product # R937 BBE# 31-05-21 (May 31, 2021)