D-0083-2023 Class II Terminated

Recalled by Atlantic Management Resources Ltd. — Westborough, MA

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