This page has been archived on the Web

Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.

Archived

This page has been archived on the Web.

Health product recall

Choletec

Starting date:
August 9, 2012
Posting date:
September 3, 2013
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-23875

Recalled Products

A. Choletec

Reason

This recall has been initiated due to potential presence of particles below 0.22 micron in the final drug product.

Depth of distribution

Hospitals (Nuclear medicine department or establishment buyer or pharmacist) in Canada.

Affected products

A. Choletec

DIN, NPN, DIN-HIM
No Market Authorization
Dosage form

Lyophilized powder

Strength

45 mg/vial

Lot or serial number
  • Lot C0672A
  • Lot C0689A
  • Lot C0799A
Companies
Recalling Firm
Bracco Imaging Canada Inc.
11065, Louis H. Lafontaine Blvd.
Anjou
H1J 2Z4
Quebec
CANADA
Marketing Authorization Holder
Bracco Imaging Canada Inc.
11065, Louis H. Lafontaine Blvd.
Anjou
H1J 2Z4
Quebec
CANADA

Date modified: