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Vinalac Probiotic Formula (October 30, 2008)

Report a Concern
Starting date:
October 30, 2008
Posting date:
March 02, 2009
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-2009A24

Reason

The product poses an unacceptable risk to health since it does not possess a marketing authorization and it is intended to be used in pregnant women.

Depth of distribution

Distribution by wholesalers to retail level. Sold within Canada since September 25, 2008.

Affected products

Vinalac Probiotic Formula

DIN, NPN, DIN-HIM

No market authorization

Dosage form

Tablet

Strength

  • Beta-carotene (Betacarotene) 1500 ?g RAE*
  • Vitamin D (Cholecalciferol) 10 ?g
  • Vitamin E (all rac-? tocopheryl acetate) 6.9 mg AT**
  • Vitamin C (L-ascorbic acid) 120 mg
  • Thiamine (Vitamin B1) (Thiamine mononitrate) 2.1 mg
  • Riboflavin (Vitamin B2) (Riboflavin) 2.4 mg
  • Niacinamide (Vitamin B3) (Niacinamide) 27 mg
  • Vitamin B6 (pyridoxine hydrochloride) 4 mg
  • Vitamin B12 (cyancobalamin) 2 ?g
  • Folate (folic acid) 400 ?g
  • Biotin (Biotin) 100 ?g
  • Pantothenic acid (calcium d-pantothenate) 12 mg
  • Iron (iron (II) fumarate) 28 mg
  • Magnesium (magnesium oxide) 75 mg
  • Zinc (zinc citrate) 7.5 mg
  • Iodine (potassium iodide) 150 ?g
  • Copper (copper (II) citrate) 1100 ?g
  • Manganese (manganese carbonate) 1.8 mg
  • Selenium (sodium selenite) 70 ?g
  • Chromium (chromium (III) chloride hexahydrate) 25 ?g
  • Molybdenum (ammonium molybdate tetrahydrate) 75 ?g
  • Lactobacillus rhamnosus (probiotic) 109 c.f.u
  • ( 1 billion bacteria)
  • Zingiber officinale Roscoe (Ginger) (dried rizhome) 30 mg
  • * Retinol activity equivalent **alpha-tocopherol equivalent

Lot or serial number

1978, 1998

Companies

Recalling Firm
Novogen Canada Ltd.
109 Thomas Street, Box 69625
Oakville Ontario
Canada L6J 7R4
Marketing Authorization Holder
Not Applicable