TORONTO, April 15, 2013 /CNW/ - Apotex Inc. confirms that it has expanded the scope of the voluntary recall of ALYSENA 28 to all lots distributed to date. This was done as a precautionary measure while Apotex investigates the packaging flaw in the initial recall lot, which involved an incorrect placement and number of active tablets and placebos.
"To date there is no evidence that the packaging flaw that led to the initial recall lot is repeated in any other lot of ALYSENA 28," stated Jack Kay, CEO of Apotex. "However, Apotex is proactively taking additional measures to ensure that this product meets Apotex's high quality standards."
Apotex, the distributor of this product in Canada, is working closely with the fabricator, Laboratorios Leon Farma S.A., and Health Canada on the recall.
In addition, Apotex has committed to a full visual inspection of each blister from all new lots of ALYSENA 28, as well as ALYSENA 21, that Apotex has received from Leon Farma. ALYSENA 21 is not part of the current recall, but Apotex is still taking the additional step of reinspecting the lots that Apotex has not yet released, as a precautionary measure, because this product is also made in Leon Farma's same facility. "To ensure the highest level of certainty, these new lots of ALYSENA 28 and ALYSENA 21 will be fully reinspected visually by Apotex before going into the marketplace," commented Mr. Kay.
"Also, in an effort to support Pharmacists' efforts, Apotex has established a toll free number (Phone 1-866-367-4537) for patients, pharmacists and health care professionals," concluded Mr. Kay.
Further details of the April 12, 2013 drug recall and advisory are posted on the Apotex Website http://www.apotex.com/ca/en/pubadvisories/default.asp.
SOURCE: Apotex Inc.
For further information:
Mr. Elie Betito, Director, Public and Government Affairs
Tel: 416-749-9300 Ext. 7366, Cell: 416-558-5491