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Health product recall

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

  1. 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

Date modified: