Reported Mar 20, 2013 · Terminated
PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension (30 ampules/carton) NDC: 0186-1988-04
AstraZeneca LP
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AstraZeneca LP · 50 Otis Street · Westborough, MA · 01581-4500
Is this the product you have?
- PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation
- Suspension (30 ampules/carton) NDC0186-1988-04
- Lot codes and dates
- Lot/Exp date
AH0054 Exp 5/14AK0125 Exp 7/14
- Lot/Exp date
- Amount recalled
- 28,476 cartons
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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