Class II
Terminated
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.
This recall has been terminated (originally issued December 21, 2022).
- Recall Initiated
- December 12, 2022
- Posted
- December 21, 2022
- Recall Number
- D-0083-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 72 bottles
- Firm Location
- Westborough, MA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
cGMP Deviations
Distribution
Nationwide and Australia
Lot / Code Info
Lot Code B-02
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