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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
CapsuleStrength
N/ALot or serial number
1008061, 1011086, 1104069Companies
- 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