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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
- Date modified: