PlainRecalls
FDA Drug Low Class III Terminated

PULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Suspension NDC: 0186-1989-04

Reported: March 20, 2013 Initiated: January 11, 2013 #D-199-2013

Product Description

PULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Suspension NDC: 0186-1989-04

Reason for Recall

Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.

Details

Recalling Firm
AstraZeneca LP
Units Affected
64675 cartons
Distribution
Nationwide
Location
Westborough, MA

Frequently Asked Questions

What product was recalled?
PULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Suspension NDC: 0186-1989-04. Recalled by AstraZeneca LP. Units affected: 64675 cartons.
Why was this product recalled?
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 20, 2013. Severity: Low. Recall number: D-199-2013.