Drug Enforcement D-0084-2023

cGMP Deviations

Status

Terminated

Classification

Class II

Report Date

December 21, 2022

Termination Date

September 20, 2023

Product Information

Product description
Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-711-01.
Product quantity
26 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-0084-2023
Event ID
91243
Recall initiation date
December 12, 2022
Center classification date
December 13, 2022
Code info
Lot Code A-01
More code info
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