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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