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Health product recall

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

  1. 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

Date modified: