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Health product recall

SourceCF Pediatric Drops

Starting date:
February 8, 2013
Posting date:
March 1, 2013
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-23803

Recalled Products

A. SourceCF Pediatric Drops

Reason

Data suggests the formulation is not supportive of the product’s shelf-life as described on the label.

Depth of distribution

Hospitals and clinics in the following provinces: Ontario, Manitoba, Nova Scotia, Newfoundland and Labrador, Prince Edward Island, Saskatchewan, New Brunswick and Alberta.

Affected products

A. SourceCF Pediatric Drops

DIN, NPN, DIN-HIM
No Market Authorization
Dosage form

Pediatric Drops

Strength

For 1 mL serving size:
Vitamin A: 4,627 IU, Vitamin C: 45 mg, Vitamin D: 500 IU, Vitamin E: 50 IU, Thiamin: 0.5 mg, Riboflavin: 0.6 mg, Niacin: 6 mg, Vitamin B-6: 0.6 mg, Vitamin B-12: 4 mcg, Biotin: 15 mcg, Pantothenic Acid: 3mg, Zinc: 5 mg, Vitamin K: 400 mcg.

Lot or serial number
  • 1BA67
  • 1DC02
  • 2BA86
  • 2FA92
Companies
Recalling Firm
Aptalis Pharma
597 Laurier Blvd.
Mount St. Hillaire
J3H 6C4
Quebec
CANADA
Marketing Authorization Holder
N/A

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