FDA Recall D-0629-2025
Atlantic Management Resources Ltd. · Westborough, MA
Class II Ongoing 260 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Reason for recall
cGMP violations
Recall record
- Recall number
D-0629-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Product was distributed via the internet.
- Recall initiated
- 2025-08-27
- Classified by FDA Center
- 2025-09-10
- FDA published
- 2025-09-17
- Recalling firm
- Atlantic Management Resources Ltd.
- Firm location
- Westborough, MA
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.