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Health product recall

RoxyLean / RoxyLean ECA

Starting date:
August 31, 2011
Posting date:
October 3, 2011
Type of communication:
Recall
Subcategory:
Drugs
Hazard classification:
Type II
Source of recall:
Health Canada
Identification number:
RA-2011A171

Reason

Product has numerous labelling violations including the fact that the quantities of all medicinal ingredients are not listed on the label. There is also a safety concern with the high level of caffeine in the product. The risk statements on the label are insufficient for pregnant and breastfeeding women.

Depth of distribution

RoxyLean was also sold to retail stores in NS, QC, ON, MB, SK, AB, and BC.

Affected products

RoxyLean / RoxyLean ECA

DIN, NPN, DIN-HIM

Product is not market authorized.(The most recent PLA for RoxyLean is # 174984)

Dosage form

Capsule

Strength

N/A

Lot or serial number

1008061, 1011086, 1104069

Companies

Recalling Firm
Peak Performance Products Inc. 86 Carrier Drive Etobicoke, ON M9W 5R1
Marketing Authorization Holder
Peak Performance Products Inc. 86 Carrier Drive Etobicoke, ON M9W 5R1