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Alysena 28 - Expanded (Additional lots)

Starting date:
April 12, 2013
Posting date:
April 15, 2013
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-26793

Recalled Products

A. Alysena 28

Reason

Further to the previous recall posted on April 8, 2013, Apotex is recalling additional lots of Alysena-28 birth control pills as a precautionary measure.

Lot LF01899A was originally recalled as packaged product may contain two rows of white (placebo) tablets (14 tablets) and two rows of pink (active) contraceptive tablets (14 tablets) in the blister pack.

Correct packaging is one row of white (placebo) tablets (7 tablets) and three rows of pink (active) contraceptive tablets (21 tablets) in the blister pack.

All lots distributed to date are being recalled as a precautionary measure while the firm investigates a packaging defect found in the original recalled lot (LF01899A).

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

Wholesalers/distributors and retailers in AB, BC, MB, NB, NF, NS, NT, ON, PE, QC, SK.

Affected products

A. Alysena 28

DIN, NPN, DIN-HIM
DIN 02387883
Dosage form

Tablets

Strength

100 mcg levonorgestrel and 20 mcg ethinyl estradiol

Lot or serial number
  • LF01899A
  • LF01898A
  • LF01894B
  • LF01901A
  • LF01900A
  • LF01980A
  • LF01982A
  • LF01981A
  • LF01979A
  • LF02037A
  • LF02036A
  • LF02026A
Companies
Recalling Firm
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
Marketing Authorization Holder
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA

Advisory