Recalls and alerts more than 4 years old are automatically archived. While this information can still be accessed in the database, it has not been altered or updated since it was archived. Web pages that are archived on the Web are not subject to the Government of Canada Web Standards. As per the Communications Policy of the Government of Canada, you can request alternate formats by contacting us.

OHG ESLEEPING (May 31, 2007)

Report a Concern
Starting date:
May 31, 2007
Posting date:
June 25, 2007
Type of communication:
Drug Recall
Subcategory:
Natural health products
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-2007A36

Reason

Health Canada analysed a sample of Optimum Health Care SleePlus TCM, which contains the same formulation as OHG ESLEEPING, and found that it contained an undeclared drug, clonazepam at 0.67 mg/capsule. The label indicates "one capsule per day 30 min before sleep". Clonazepam, an anticonvulsant, is listed in Schedule IV(18)(6) of the Controlled Drugs and Substances Act (CDSA).

Depth of distribution

1. Optimum Herbal Group Ltd. has given 60 bottles labelled as OHG ESLEEPING as samples and gifts to friends in Canada, USA and Taiwan. 2. Optimum Herbal Group Ltd. exported 648 bottles to China under the label "OHG ESLEEPING Dietary Supplement".

Affected products

OHG ESLEEPING

DIN, NPN, DIN-HIM

No market authorization

Dosage form

Capsules

Strength

  • 40 mg/capsule of herbal ingredients.

Lot or serial number

OP4001209

Companies

Recalling Firm
Optimum Herbal Group Ltd.
305-2150 West Broadway
Vancouver British Columbia
Canada V6K 4L9
Marketing Authorization Holder
Optimum Herbal Group Ltd.
305-2150 West Broadway
Vancouver British Columbia
Canada V6K 4L9