FDA recall D-0083-2023

Atlantic Management Resources Ltd. · Class II · drug

Product

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.

Reason for recall

cGMP Deviations

Distribution

Nationwide and Australia

Key facts

Status: Terminated
Initiation date: 2022-12-12
Report date: 2022-12-21
Termination date: 2023-09-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Westborough, MA, United States

Primary source

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