This page has been archived on the Web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.
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 00893722Dosage 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