FDA-Drug2022-12-21Class II

ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Dist. by: Endometriosis Assoc. Inc. (International), Mfg. by Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-712-01.

Atlantic Management Resources Ltd.
Hazard

cGMP Deviations

Sold states
Nationwide and Australia
Affected count
72 bottles
Manufactured in
39 Harvey Ln, N/A, Westborough, MA, United States
Products
ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Dist. by: Endometriosis Assoc. Inc. (International), Mfg. by Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-712-01.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0083-2023

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