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Fluotic (June 01, 2007)

Starting date:
June 01, 2007
Posting date:
July 09, 2007
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-2007A42

Reason

The disintegration of the tablet in gastric fluid is out of specification

Depth of distribution

Distribution to drugstores and hospitals in Canada only

Affected products

Fluotic

DIN, NPN, DIN-HIM

DIN 02099225

Dosage form

Tablet

Strength

  • 20 mg

Lot or serial number

8034613

Companies

Recalling Firm
Sanofi-Aventis
2150 Saint Elzear Blvd. West
Laval Quebec
Canada H7L 4A8
Marketing Authorization Holder
Sanofi-Aventis
2150 Saint Elzear Blvd. West
Laval Quebec
Canada H7L 4A8