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Health product recall

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 02267217
Dosage 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