Status
Terminated
Drug Enforcement D-0083-2023
cGMP Deviations
Classification
Class II
Report Date
December 21, 2022
Termination Date
September 20, 2023
Product Information
- Product description
- 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.
- Product quantity
- 72 bottles
- Reason for recall
- cGMP Deviations
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Nationwide and Australia
Location & Firm
- Recalling firm
- Atlantic Management Resources Ltd.
- Address
-
39 Harvey Ln, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0083-2023
- Event ID
- 91243
- Recall initiation date
- December 12, 2022
- Center classification date
- December 13, 2022
- Code info
- Lot Code B-02
- More code info
- —