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ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Dist. by...

FDA Recall #D-0083-2023 — Class II — December 12, 2022

Recall #D-0083-2023 Date: December 12, 2022 Classification: Class II Status: Terminated

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

Recalling Firm

Atlantic Management Resources Ltd. — Westborough, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

72 bottles

Distribution

Nationwide and Australia

Code Information

Lot Code B-02

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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