Drug 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
D-0629-2025
Product summary
- Event
- Event 97345
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 72 containers
- Official record key
drug-enforcement:D-0629-2025
Official wording
Reason: cGMP violations
Code information: 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)
Distribution pattern: Product was distributed via the internet.
Derived failure modes
-
Manufacturing or process control
cGMP violations