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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Topical Products

Neuroquell, ProSirona, and Menastil Recalled for Manufacturing Deviations

Agency Publication Date: December 13, 2022
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Summary

Atlantic Management Resources Ltd. is recalling approximately 610 bottles of Neuroquell, ProSirona, and Menastil homeopathic drug products. The recall was initiated due to manufacturing deviations that do not comply with Good Manufacturing Practice (cGMP) standards. The affected products include various formulas of Calendula Oil packaged in small bottles (0.22 fl. oz. and 1/8 fl. oz.) which were distributed across the United States and Australia.

Risk

Failure to follow manufacturing quality standards can result in products that are inconsistent in strength or quality, or potentially contaminated. While no injuries or illnesses have been reported to date, these manufacturing defects could pose health risks to users.

What You Should Do

  1. This recall affects Neuroquell Plus, Neuroquell, ProSirona, and Menastil homeopathic topical oils sold in 0.22 fl. oz. and 1/8 fl. oz. bottles.
  2. Check your product packaging for the following identifying codes: Neuroquell and ProSirona bottles with Lot Code B-02 (NDC 66233-712-01), or Menastil bottles with Lot Code A-01 (NDC 66233-711-01).
  3. If you have health concerns, contact your healthcare provider or pharmacist.
  4. Return any unused product to the place of purchase for a refund, throw it away, or contact Atlantic Management Resources Ltd. or Claire Ellen Topicals for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil (0.22 fl. oz. / 6.6 mL)
Variants: Advanced Formula, Calendula Oil
Lot Numbers:
B-02
NDC:
66233712-01

Quantity: 461 bottles distributed.

Product: Neuroquell, A Homeopathic Drug, Calendula Oil (1/8 fl. oz. / 3.5 g)
Variants: Calendula Oil
Lot Numbers:
B-02
NDC:
66233712-01

Quantity: 51 bottles distributed.

Product: ProSirona, A Homeopathic Formula, Calendula Oil (1/8 fl. oz. / 3.5 g)
Variants: Calendula Oil
Lot Numbers:
B-02
NDC:
66233-712-01

Distributed by Endometriosis Assoc. Inc. (International). Quantity: 72 bottles distributed.

Product: Menastil, A Homeopathic Formula, Calendula Oil (1/8 fl. oz. / 3.5 g)
Variants: Calendula Oil
Lot Numbers:
A-01
NDC:
66233-711-01

Quantity: 26 bottles distributed.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91243
Status: Resolved
Manufacturer: Atlantic Management Resources Ltd.
Sold By: Claire Ellen Topicals; Endometriosis Assoc. Inc. (International)
Manufactured In: United States
Units Affected: 4 products (461 bottles; 51 bottles; 72 bottles; 26 bottles)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.