D-0083-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 21, 2022
- Initiation Date
- December 12, 2022
- Termination Date
- September 20, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 72 bottles
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.
Reason for Recall
cGMP Deviations
Distribution Pattern
Nationwide and Australia
Code Information
Lot Code B-02