Recalls / Class II
Class IID-0082-2023
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.
- Affected lot / code info
- Lot Code B-02
Why it was recalled
cGMP Deviations
Recalling firm
- Firm
- Atlantic Management Resources Ltd.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 39 Harvey Ln, N/A, Westborough, Massachusetts 01581-3013
Distribution
- Quantity
- 51 bottles
- Distribution pattern
- Nationwide and Australia
Timeline
- Recall initiated
- 2022-12-12
- FDA classified
- 2022-12-13
- Posted by FDA
- 2022-12-21
- Terminated
- 2023-09-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0082-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.