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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

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