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Health product recall

LEO 22811-S22 Proof of Concept Study (Phase II)

Starting date:
September 24, 2010
Posting date:
October 25, 2010
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Product Safety, Quality
Audience:
Healthcare Professionals, General Public, Hospitals
Identification number:
RA-2010A229

Recalled products

  1. LEO 22811-S22 Proof of Concept Study (Phase II)

Reason

Broken bottles and loose caps have been identified. A significant part of the bottles with loose caps are leaking.

Depth of distribution

The IMP has been distributed to six clinical sites in France, four clinical sites in Canada as well as one central depot in both France and Canada.

Affected products

LEO 22811-S22 Proof of Concept Study (Phase II)

DIN, NPN, DIN-HIM
N/A -Clinical Trial (IMP)
Dosage form
  • Oral Solution
Strength
  • 0.1875 mg/mL of LEO 22811
Lot or serial number
  • Bulk Batch No. 09 304 74 01
  • Secondary Packaging Code (Aptuit) CT 2673/1, CT 2673/4, CT2673/5
Companies
Recalling Firm
LEO Pharma 123 Commerce Valley Drive East, Suite 400, Thornhill, Ontario L3T 7W8
Marketing Authorization Holder
N/A
Recalling Firm
LEO Pharma
123 Commerce Valley Drive East, Suite 400,
Thornhill
L3T 7W8
Ontario
CANADA
Marketing Authorization Holder
LEO Pharma
123 Commerce Valley Drive East, Suite 400,
Thornhill
L3T 7W8
Ontario
CANADA

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