This page has been archived on the Web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.
Ortho-Cept Tablets (28 DAY) (2015-04-24)
- Starting date:
- April 24, 2015
- Posting date:
- April 27, 2015
- Type of communication:
- Drug Recall
- Subcategory:
- Drugs
- Hazard classification:
- Type I and II
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-53137
Recalled Products
Ortho-Cept Tablets (28 DAY)
Reason
Out of Specification results for active pharmaceutical ingredients (desogestrel and ethinyl estradiol) during stability testing at 30 months (expiry 36 months). Type I risk to health for patients who should not get pregnant, whether for medical reasons or exposure to agents detrimental to a developing fetus. Type II risk for the general population.
Depth of distribution
Patient level (pharmacies to contact their patients)
Affected products
Ortho-Cept Tablets (28 DAY)
DIN, NPN, DIN-HIM
DIN 02042533Dosage form
Tablet
Strength
Desogestrel 0.15 mg
Ethinyl Estradiol 0.03 mg
Lot or serial number
13DM732
Companies
- Recalling Firm
-
Janssen Inc.
19 Greenbelt Drive
Toronto
M3C 1L9
Ontario
CANADA
- Marketing Authorization Holder
-
Janssen Inc.
19 Greenbelt Drive
Toronto
M3C 1L9
Ontario
CANADA