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Recall Observatory FDA recall evidence

Drug product

PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension (30 ampules/carton) NDC: 0186-1988-04

D-198-2013

January 11, 2013

Class III

Product summary

Firm
AstraZeneca LP
Event
Event 64041
Status
Terminated
Classification
Class III
Quantity
28,476 cartons
Official record key
drug-enforcement:D-198-2013

Official wording

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

Code information: Lot/Exp date: AH0054 Exp 5/14; AK0125 Exp 7/14

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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