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D-0083-2023 Class II Terminated

Recalled by Atlantic Management Resources Ltd. — Westborough, MA

FDA drug recall D-0083-2023 was initiated by Atlantic Management Resources Ltd. on Dec 12, 2022 and is designated Class II. Reason for recall: cGMP Deviations The recall status is terminated (terminated Sep 20, 2023). Affected quantity: 72 bottles.

Recall Details

Product Type: Drugs
Report Date: Dec 21, 2022
Initiation Date: Dec 12, 2022
Termination Date: Sep 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

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0083-2023
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by Atlantic Management Resources Ltd.

D-0629-2025 Class II — Neuroquell & Neuroquell Plus, .22 fl. Oz (6.6mL),Mfg. For/Dist. By Claire Ellen… (Aug 27, 2025)
D-0084-2023 Class II — Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g)… (Dec 12, 2022)
D-0082-2023 Class II — Neuroquell, A Homeopathic Drug, Calendula Oil, packaged in1/8 Fl. oz. (3.5 g)… (Dec 12, 2022)
D-0081-2023 Class II — Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged in… (Dec 12, 2022)