Drug Neuroquell Plus Calendula Oil Recalled for Manufacturing Deviations
Neuroquell Plus, a homeopathic calendula oil drug, has been voluntarily recalled due to current good manufacturing practice (cGMP) deviations. The recall affects 461 bottles distributed nationwide and in Australia.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall without reported illnesses, injuries, or hospitalization records. The manufacturer voluntarily initiated this precautionary recall for manufacturing practice deviations with no documented health impacts. Per the rubric, voluntary precautionary recalls without reported illness fall into the Moderate category.
Plain-English summary
Neuroquell Plus Advanced Formula is a homeopathic drug containing calendula oil, packaged in 0.22 fl oz (6.6 mL) bottles with lot code B-02. The recall affects 461 bottles manufactured by Atlantic Management Resources Ltd. and distributed by Claire Ellen Topicals in Westborough, Massachusetts.
The recall was initiated due to current good manufacturing practice (cGMP) deviations in the manufacturing process. The firm voluntarily initiated the recall on December 12, 2022.
The product was distributed nationwide throughout the United States and in Australia. Consumers who possess this product should stop using it and may consult a healthcare provider if they have any health concerns. The recall status was terminated on September 20, 2023.
The recalled product
- Product
- 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.
- Manufacturer
- Atlantic Management Resources Ltd.
- Category
- Drug — Homeopathic
- Hazard
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Code B-02
Distribution
Distributed nationwide across the United States.
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