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.
Reported: December 21, 2022 Initiated: December 12, 2022 #D-0083-2023
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
Details
- Recalling Firm
- Atlantic Management Resources Ltd.
- Units Affected
- 72 bottles
- Distribution
- Nationwide and Australia
- Location
- Westborough, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Atlantic Management Resources Ltd.. Units affected: 72 bottles.
Why was this product recalled? ▼
cGMP Deviations
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 21, 2022. Severity: Moderate. Recall number: D-0083-2023.
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