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Viokace (2017-12-05)
- Starting date:
- December 5, 2017
- Posting date:
- December 20, 2017
- 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-65480
Affected products
Viokace
Reason
Out of specification for enzyme profile during stability testing in affected lot.
Depth of distribution
Wholesalers and pharmacies across Canada
Affected products
Viokace
DIN, NPN, DIN-HIM
DIN 02230019
Dosage form
Tablet
Strength
Lipase 10,440 USP units
Amylase 56,400 USP units
Protease 57,100 USP units
Lot or serial number
160229A
Companies
- Recalling Firm
-
Allergan Inc.
85 Enterprise Blvd, Suite 500
Markham
L6G 0B5
Ontario
CANADA
- Marketing Authorization Holder
-
Aptalis Pharma Canada ULC
(an Allergan affiliate)
85 Enterprise Blvd, Suite 500
Markham
L6G 0B5
Ontario
CANADA