FDA Drug Recalls

Recalls / Class II

Class IID-0084-2023

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.

Affected lot / code info
Lot Code A-01

Why it was recalled

cGMP Deviations

Recalling firm

Firm
Atlantic Management Resources Ltd.
Notification channel
Telephone
Type
Voluntary: Firm initiated
Address
39 Harvey Ln, N/A, Westborough, Massachusetts 01581-3013

Distribution

Quantity
26 bottles
Distribution pattern
Nationwide and Australia

Timeline

Recall initiated
2022-12-12
FDA classified
2022-12-13
Posted by FDA
2022-12-21
Terminated
2023-09-20
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0084-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.