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Serophene (2014-08-26)

Starting date:
August 26, 2014
Posting date:
September 2, 2014
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-41271

Recalled Products

Serophene

Reason

Report of a new impurity (bromo analogue of Clomiphene Citrate) at above ICH specification (NMT 0.10%) level in API batches used in manufacture of Serophene 50mg tablets.

Depth of distribution

Pharmacies, clinics, wholesalers

Affected products

Serophene Tab 50 mg

DIN, NPN, DIN-HIM
DIN 00893722
Dosage form

Tablet

Strength

50 mg

Lot or serial number
  • S54009
  • S54011
  • S54012
  • S54013
  • S54015
  • S61003
Companies
Recalling Firm
EMD SERONO (A DIVISION OF EMD INC., CANADA)
2695 North Sheridan Way, Suite 200
Mississauga
L5K 2N6
Ontario
CANADA
Marketing Authorization Holder
EMD SERONO (A DIVISION OF EMD INC., CANADA)
2695 North Sheridan Way, Suite 200
Mississauga
L5K 2N6
Ontario
CANADA