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Health product recall

Ashwagandha (2016-03-18)

Starting date:
March 18, 2016
Posting date:
April 8, 2016
Type of communication:
Drug Recall
Subcategory:
Natural health products
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-57862

Affected Products:

Ashwagandha

Reason

Incorrect labelling; including an incomplete list of caution and warning statements.

Depth of distribution

Retailers (British Columbia, Alberta, Ontario, Quebec)

Affected products

Ashwagandha

DIN, NPN, DIN-HIM
NPN 80041941
Dosage form

Caplets

Strength

Withania somnifera 10.0mg (100:1, DHE 1000mg)
Withania somnifera 380.0mg
Withania somnifera 280.0mg (6.67:1, DHE 1867.6mg)

Lot or serial number

Lot 11500246
Lot 11500247
Lot 11502085

Companies
Recalling Firm
Peak Performance Products Inc.
6819 Steeles Avenue West
Etobicoke
M9V 4R9
Ontario
CANADA
Marketing Authorization Holder
The Himalaya Drug Company
1101 Gillingham Lane
Sugar Land
77478
Texas
UNITED STATES

Date modified: