This page has been archived on the Web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.

Health product recall

Pulmicort Nebuamp - (0.125 mg/mL, 0.25 mg/mL, 0.5 mg/mL)

Starting date:
January 28, 2013
Posting date:
February 18, 2013
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-23313

Recalled Products

Pulmicort Nebuamp - 0.125 mg/mL, 0.25 mg/mL, 0.5 mg/mL

Reason

Budesonide content in a small number of ampoules may be above or below the specification range.

Depth of distribution

Retailers nationwide

Affected products

A. Pulmicort Nebuamp 0.125 mg/mL

DIN, NPN, DIN-HIM

DIN 02229099

Dosage form

2 ml ampoules

Strength

0.125 mg/mL

Lot or serial number

YM0042

Companies
Recalling Firm

AstraZeneca Canada Inc. 1004 Middlegate Road Mississauga, Ontario L4Y 1M4

Marketing Authorization Holder

AstraZeneca Canada Inc. 1004 Middlegate Road Mississauga, Ontario L4Y 1M4


B. Pulmicort Nebuamp 0.25 mg/mL

DIN, NPN, DIN-HIM

DIN 01978918

Dosage form

2 mL ampoules

Strength

0.25 mg/mL

Lot or serial number

WT0023, AC0180, AN0086

Companies
Recalling Firm

AstraZeneca Canada Inc. 1004 Middlegate Road Mississauga, Ontario L4Y 1M4

Marketing Authorization Holder

AstraZeneca Canada Inc. 1004 Middlegate Road Mississauga, Ontario L4Y 1M4


C. Pulmicort Nebuamp  0.5 mg/mL

DIN, NPN, DIN-HIM

DIN 01978926

Dosage form

2 mL ampoules

Strength

0.5 mg/mL

Lot or serial number

AB0126

Companies
Recalling Firm

AstraZeneca Canada Inc. 1004 Middlegate Road Mississauga, Ontario L4Y 1M4

Marketing Authorization Holder

AstraZeneca Canada Inc. 1004 Middlegate Road Mississauga, Ontario L4Y 1M4