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Class II: temporary or reversible health riskTerminated

Atlantic Management Resources ProSirona Recall

ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl

Atlantic Management Resources Ltd. · Westborough, MA

Risk level
Class II
Reported by FDA
Dec 21, 2022
Recall ID
D-0083-2023
Check your lot numberHow we source this data

Summary

Atlantic Management Resources recalled ProSirona starting Dec 12, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0083-2023 on Dec 21, 2022. Reason: cGMP Deviations. Status: Terminated.

Why it was recalled

cGMP Deviations

Product 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.

Lot numbers, UPCs & expiration codes

Lot Code B-02

Where it was sold

Nationwide and Australia

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0083-2023
Classification
Class II
Status
Terminated
Recall initiated
Dec 12, 2022
FDA report date
Dec 21, 2022
Quantity
72 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Atlantic Management Resources Ltd.

Original FDA data

Every field from FDA enforcement report D-0083-2023, exactly as published.

Show all FDA fields
City
Westborough
State
MA
Status
Terminated
Country
United States
Event ID
91243
Address
39 Harvey Ln
Code information
Lot Code B-02
Postal code
01581-3013
Report date
Dec 21, 2022
Product type
Drugs
Recall number
D-0083-2023
Classification
Class II
Recalling firm
Atlantic Management Resources Ltd.
Product quantity
72 bottles
Termination date
Sep 20, 2023
Reason for recall
cGMP Deviations
Voluntary / mandated
Voluntary: Firm initiated
Product 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.
Distribution pattern
Nationwide and Australia
Recall initiation date
Dec 12, 2022
Initial firm notification
Telephone
Center classification date
Dec 13, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0083-2023, published Dec 21, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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