FDA recall D-0081-2023

Atlantic Management Resources Ltd. · Class II · drug

Product

Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged in 0.22 Fl. oz. (6.6 mL) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01.

Reason for recall

cGMP Deviations

Distribution

Nationwide and Australia

Key facts

Status
Terminated
Initiation date
2022-12-12
Report date
2022-12-21
Termination date
2023-09-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Westborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0081-2023