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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