Health product recall

Alysena 28

Starting date:
April 3, 2013
Posting date:
April 8, 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-26663

Recalled Product

  1. Alysena 28

Reason

Packaged product may contain two rows of placebo tablets (14 tablets) and two rows of active contraceptive tablets (14 tablets) in the blister pack. Correct packaging is one row of placebo tablets (7 tablets) and three rows of active contraceptive tablets (21 tablets) in the blister pack.

As per the product monograph, in the case of a missed dose, use a non-hormonal method of contraception as an interim measure until you speak with your physician and obtain medical advice.

Depth of distribution

Wholesalers/distributors and retailers in BC, NB, NF, NS, ON, PE, QC

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
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

Precautionary recall of additional lots of Alysena-28

2013-04-12 | Health products

Advisory