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

• 
  Reason
• 
  Depth of distribution
• 
  Affected products
• 
  Related AWRs

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

Related AWRs

Precautionary recall of additional lots of Alysena-28

2013-04-12 | Health products

Advisory