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.
D-0083-2023
Product summary
- Event
- Event 91243
- Status
- Terminated
- Classification
- Class II
- Quantity
- 72 bottles
- Official record key
drug-enforcement:D-0083-2023
Official wording
Reason: cGMP Deviations
Code information: Lot Code B-02
Distribution pattern: Nationwide and Australia
Derived failure modes
-
Manufacturing or process control
cGMP Deviations