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Formo Cresol Liquid (October 12, 2009)

Report a Concern
Starting date:
October 12, 2009
Posting date:
November 23, 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-2009A134

Reason

Failed stability for percent cresol and formaldehyde content at 24-month shelf life.

Depth of distribution

Dentist Offices

Affected products

Formo Cresol Liquid

DIN, NPN, DIN-HIM

NPN 00470236

Dosage form

Liquid

Strength

  • 48.5 % w/w - Cresol
  • 48.5% w/w - formaldehyde

Lot or serial number

110925952, 0710080703

Companies

Recalling Firm
VDI Healthcare
250 First Gulf Blvd.
Brampton Ontario
Canada L6W 4T5
Marketing Authorization Holder
Sultan Healthcare
411 Hackensack Ave.
Hackensack New Jersey
United states ÉTATS-UNIS 07601