Drug Enforcement D-0082-2023

cGMP Deviations

Status

Terminated

Classification

Class II

Report Date

December 21, 2022

Termination Date

September 20, 2023

Product Information

Product description
Neuroquell, A Homeopathic Drug, Calendula Oil, packaged in1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01.
Product quantity
51 bottles
Reason for recall
cGMP Deviations
Recall initiation reason
—
Initial firm notification
Telephone
Distribution pattern
Nationwide and Australia

Location & Firm

Recalling firm
Atlantic Management Resources Ltd.
Address
39 Harvey Ln, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0082-2023
Event ID
91243
Recall initiation date
December 12, 2022
Center classification date
December 13, 2022
Code info
Lot Code B-02
More code info
—