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Health product recall

Bravelle (2015-10-23)

Starting date:
October 23, 2015
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-55684

Affected Products

Bravelle

Reason

Out of specification result for potency during shelf life testing.

Depth of distribution

Clinics, hospitals and/or wholesalers in all provinces/territories

Affected products

Bravelle

DIN, NPN, DIN-HIM

DIN 02268140

Dosage form

Poudre lyophilisée stérile pour injection

Strength

Urofollitropin 75 IU

Lot or serial number

Lot H15940B

Lot H15940C

Lot K16990B

Lot K16990C

Companies
Recalling Firm

Ferring Inc.

200 Yorkland Blvd., Suite 800,

North York

M2J 5C1

Ontario

CANADA

Marketing Authorization Holder

Ferring Inc.

200 Yorkland Blvd., Suite 800,

North York

M2J 5C1

Ontario

CANADA