D-0084-2023 Class II Terminated

Recalled by Atlantic Management Resources Ltd. — Westborough, MA

FDA drug recall D-0084-2023 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: 26 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
26 bottles

Product Description

Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-711-01.

Reason for Recall

cGMP Deviations

Distribution Pattern

Nationwide and Australia

Code Information

Lot Code A-01

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0084-2023
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.

Source: openFDA record for D-0084-2023. Report a data issue: hello@regdatalab.com.