FDA Drug recall D-0083-2023
ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Dist. by: Endometriosis Assoc
- FDA Drug
- Class II
- terminated
- Published 2022-12-21
On 2022-12-21 the FDA classified a Class II recall of ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Dist. by: Endometriosis Assoc by Atlantic Management Resources, citing cGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0083-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-12-12 |
| Published | 2022-12-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Atlantic Management Resources |
| Distribution | US |
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
cGMP Deviations
Identifiers
| code_info | Lot Code B-02 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0083-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.