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W.-W. (2015-04-01)
- Starting date:
- April 1, 2015
- Posting date:
- April 7, 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-52817
Recalled Products
W.-W.
Reason
Recall initiated following suspension of market authorisation by Health Canada. The oral use by self medicating of the ingredient Dryopteris filix-mas in the natural health products 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
Naturopaths, Independent distributors
Affected products
W.-W.
DIN, NPN, DIN-HIM
NPN 80055739Dosage form
Liquids
Strength
- Artemisia vulgaris 2.61 mL (1 : 7 DHE: 372.86 mg)
- Cucurbita pepo 4.18 mL (1.0 : 3.0 DHE: 1393.3 mg Dry)
- Dryopteris filix-mas 2.15 mL (1.0 : 4.0 DHE: 537.5 mg Dry)
- Frangula purshiana 3.87 mL (1.0 : 5.0 DHE: 774 mg Dry)
- Juglans nigra 2.18 mL (1 : 4 DHE: 545 mg)
Lot or serial number
- 50233
- 41018
Companies
- Recalling Firm
-
Les Herbes Pures J.B. Ltée
351-10e Sud Avenue
Sherbrooke
J1G 2R8
Quebec
CANADA
- Marketing Authorization Holder
-
Les Herbes Pures J.B. Ltée
351-10e Sud Avenue
Sherbrooke
J1G 2R8
Quebec
CANADA
Related AWRs
2015-04-02 | Health products
Advisory