CALENDULA OFFICINALIS FLOWERING TOP Recall D-0083-2023
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.
CALENDULA OFFICINALIS FLOWERING TOP Recall D-0083-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0083-2023 |
| Event ID | 91243 |
| Brand | NEUROQUELL |
| Generic Name | NEUROQUELL |
| Manufacturer | NEUROQUELL |
| Original Package? | 1 |
| Active Substance | CALENDULA OFFICINALIS FLOWERING TOP |
| Drug Route | TOPICAL |
| Distribution | Nationwide and Australia |
| Quantity | 72 bottles |
| Recall Reason | cGMP Deviations |
| Drug Classification | Class II |
| Drug Code Info | 20221221 |
| Product NDC | 66233-712 |
| Recall Initiation Date | 20221212 |
| Report Date | 20221221 |
| Classification Date | 20221213 |
| Address | 39 Harvey Ln Westborough, MA 01581-3013 United States |
| Recalling Firm | Atlantic Management Resources Ltd. |
| Initial Notification | Telephone |
| Unique Ingredient Identifier | 18E7415PXQ |
| Structured Product Labeling (SPL ID) | e38c7016-9cf6-0599-e053-2a95a90a2b1b |
| Structured Product Labeling (SPL Set ID) | 2cb44058-9eb1-45b2-e054-00144ff88e88 |
| Similar To |