Drug recall: Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged in 0.22 Fl. oz. (6.6 mL) bottles, Mfg. for
Atlantic Management Resources Ltd. (Westborough, MA) initiated this drug recall on 12 Dec 2022; FDA lists 4 product records under event 91243, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 65% of the 325 drug enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 20 Sep 2023. Initiation: voluntary: firm initiated. Atlantic Management Resources Ltd. has 2 enforcement events on this register, with a median of 4 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Atlantic Management Resources Ltd., Westborough, MA.
Reason for recall
"cGMP Deviations"
Distribution
"Nationwide and Australia"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0081-2023 | Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged in 0.22 Fl. oz. (6.6 mL) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01. | 461 bottles | Class II | Terminated | 21 Dec 2022 |
| D-0082-2023 | Neuroquell, A Homeopathic Drug, Calendula Oil, packaged in1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01. | 51 bottles | Class II | Terminated | 21 Dec 2022 |
| D-0083-2023 | 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. | 72 bottles | Class II | Terminated | 21 Dec 2022 |
| D-0084-2023 | 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. | 26 bottles | Class II | Terminated | 21 Dec 2022 |
Context
Other enforcement events for Atlantic Management Resources Ltd.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 27 Aug 2025 | Neuroquell & Neuroquell Plus, .22 fl. Oz (6.6mL),Mfg. For/Dist. By Claire Ellen Products, P.O. Box 901 Westboro, MA 0158 (97345) | Drug | Class II | 1 |
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "cGMP Deviations"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide and Australia"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 20 Sep 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.