This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Filix Mas (2015-04-16)
- Starting date:
- April 16, 2015
- Posting date:
- April 20, 2015
- Type of communication:
- Drug Recall
- Subcategory:
- Natural health products
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-53015
Recalled products
- Filix Mas
Reason
Recall initiated following suspension of market authorisation by Health Canada. The oral use by self medicating of the mother tincture ingredient Dryopteris filix-mas in the homeopathic product should not be authorised on the Canadian market due to unfavourable risks:benefits ratio and the fact that a "safe" dosage of Male fern cannot be determined.
Depth of distribution
Practitioner
Affected products
A. Filix Mas
DIN, NPN, DIN-HIM
DIN-HM 80018123
Dosage form
Oral drops
Strength
- Mother tincture
Lot or serial number
- L14A020124. ref.TP2525
Companies
- Recalling Firm
-
Boiron Canada Inc
1300 René Descartes
Saint-Bruno-de-Montarville
J3V 0B7
Quebec
CANADA
- Marketing Authorization Holder
-
Boiron Canada Inc
1300 René Descartes
Saint-Bruno-de-Montarville
J3V 0B7
Quebec
CANADA