This page has been archived on the Web

Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.

Archived

This page has been archived on the Web.

Health product recall

Teva-Mirtazapine

Starting date:
April 5, 2012
Posting date:
April 30, 2012
Type of communication:
Recall
Subcategory:
Drugs
Hazard classification:
Type II
Source of recall:
Health Canada
Identification number:
RA-2012A50

Reason

Upon testing the 36 month stability time points for Mirtazapine lot M31004 15 mg and lot M33004 45 mg OD Tablets (30's unit dose packaging), out of specification (OOS) and out of trend (OOT) results were identified respectively. As per specification, the limit for any individual impurity is NMT 0.2%. The results for the tested batches indicated an impurity at RRT 0.8 to be 0.3% and 0.2% respectively. Six lots within expiry will be recalled from the Canadian market.

Depth of distribution

Product was distributed to wholesalers/retailers in NF, NS, QC, ON, MB, AB, SK and BC.

Affected products

Teva-Mirtazapine

DIN, NPN, DIN-HIM

Teva-Mirtazapine OD 15 mg comprimés, DIN # 02279894 Teva Mirtazapine OD 45 mg comprimés, DIN # 02279916

Dosage form

Tablet

Strength

15 mg / tablet, 45 mg / tablet

Lot or serial number

M31006 (15 mg) M31007 (15 mg) M31008 (15 mg) M31009 (15 mg) M33006 (45 mg) M33007 (45 mg)

Companies

Recalling Firm
Teva Canada Limited 30 Novopharm Court Toronto, ON M1B 2K9
Marketing Authorization Holder
Teva Pharmaceutical 64 Hashikma Street, Industrial Zone, Kfar-Saba, Israel, 44102

Date modified: