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Asacol 800 (2013-11-27)
- Starting date:
- November 27, 2013
- Posting date:
- December 9, 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-37105
Recalled Products
Asacol 800
Reason
An impurity was above specification during shelf life testing.
Depth of distribution
Wholesalers across Canada.
Affected products
Asacol 800
DIN, NPN, DIN-HIM
DIN 02267217Dosage form
Tablet
Strength
800 mg
Lot or serial number
450654 sublots S1, S2, S3, S4
450665 sublots S1, S2, S3, S4
451559 sublots S1, S2, S3, S4
452576 sublots S1, S2
Companies
- Recalling Firm
-
Warner Chilcott Canada Co.
4711 Yonge Street, Suite 602
Toronto
M2N 6K8
Ontario
CANADA
- Marketing Authorization Holder
-
Warner Chilcott Canada Co.
4711 Yonge Street, Suite 602
Toronto
M2N 6K8
Ontario
CANADA