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Recall Observatory FDA recall evidence

Drug product

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.

D-0084-2023

December 12, 2022

Class II

Product summary

Firm
Atlantic Management Resources Ltd.
Event
Event 91243
Status
Terminated
Classification
Class II
Quantity
26 bottles
Official record key
drug-enforcement:D-0084-2023

Official wording

Reason: cGMP Deviations

Code information: Lot Code A-01

Distribution pattern: Nationwide and Australia

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP Deviations