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Seasonale
- Starting date:
- March 15, 2013
- Posting date:
- April 2, 2013
- Type of communication:
- Drug Recall
- Subcategory:
- Drugs
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-26489
Recalled Products
- Seasonale
Reason
Stability failure at 3 months testing points for the Impurity level of a US marketed product. It was determined that this impurity came from a packaging component which was also used in the impacted lots of Seasonale in Canada.
Depth of distribution
Wholesalers and pharmacies across Canada
Affected products
A. Seasonale
DIN, NPN, DIN-HIM
DIN 02296659
Dosage form
- Tablet
Strength
- Levonorgestrel 0.15 mg
- Ethinylestradiol 0.03 mg
Lot or serial number
- 33802097A
- 33802711A
- 33803162A
- 33803443A
Companies
- Recalling Firm
-
Paladin Labs Inc.
102 - 6111 Royalmount Ave.
Montreal
H4P 2P5
Quebec
CANADA
- Marketing Authorization Holder
-
Teva Womens Health Inc.
425 Privet Road
Horsham
19044
Pennsylvania
UNITED STATES