Recalls / Class III
Class IIID-198-2013
Product
PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension (30 ampules/carton) NDC: 0186-1988-04
- Brand name
- Pulmicort Respules
- Generic name
- Budesonide
- Active ingredient
- Budesonide
- Route
- Respiratory (inhalation)
- NDCs
- 0186-1988, 0186-1989, 0186-1990
- FDA application
- NDA020929
- Affected lot / code info
- Lot/Exp date: AH0054 Exp 5/14; AK0125 Exp 7/14
Why it was recalled
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Recalling firm
- Firm
- AstraZeneca LP
- Manufacturer
- AstraZeneca Pharmaceuticals LP
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 50 Otis Street, N/A, Westborough, Massachusetts 01581-4500
Distribution
- Quantity
- 28,476 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-01-11
- FDA classified
- 2013-03-12
- Posted by FDA
- 2013-03-20
- Terminated
- 2013-07-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-198-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.