D-0084-2023 Class II Terminated
FDA drug recall D-0084-2023 was initiated by Atlantic Management Resources Ltd. on December 12, 2022 and is designated Class II. Reason for recall: cGMP Deviations The recall status is terminated (terminated September 20, 2023). Affected quantity: 26 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 21, 2022
- Initiation Date
- December 12, 2022
- Termination Date
- September 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