The Recall Desk

FDA (Drugs) recall action 91243

Atlantic Management Resources Ltd. recalled 4 products on 2022-12-21

The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2022-12-21
Critical
0
Units
610

Why these products were recalled

cGMP Deviations

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–4 of 4

  • ModerateFDA (Drugs)··2022-12-21

    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.

    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2022-12-21

    FDA recalls Neuroquell Calendula Oil homeopathic drug for manufacturing deviations

    The FDA has recalled Neuroquell Calendula Oil, a homeopathic drug, due to manufacturing practice violations. The voluntary recall affected 51 bottles distributed nationwide and in Australia.

    Product
    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2022-12-21

    Drug Recall: ProSirona Homeopathic Calendula Oil Manufacturing Deviations

    ProSirona Homeopathic Calendula Oil (Lot B-02) is being recalled because the manufacturer failed to follow Current Good Manufacturing Practice standards. The voluntary recall affects products distributed nationwide and in Australia.

    Product
    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2022-12-21

    Homeopathic Calendula Oil Recalled for Manufacturing Practice Violations

    Atlantic Management Resources voluntarily recalls Menastil homeopathic calendula oil due to cGMP deviations. The 26 bottles (Lot A-01) were distributed nationwide and to Australia.

    Product
    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.
    Category
    Distribution
    0 states