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  5. FDA Recall: Pulmicort Respules

FDA Recall Pulmicort Respules

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The last Recall Enforcement Report for Pulmicort Respules with NDC 0186-1990 was initiated on 01-11-2013 as a Class III recall due to does not meet monograph: budesonide may be slightly above or below the specification range. The latest recall number for this product is D-198-2013 and the recall is currently terminated as of 07-26-2013 .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-198-201301-11-201303-20-2013Class III28,476 cartonsPULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension (30 ampules/carton) NDC: 0186-1988-04Terminated
D-199-201301-11-201303-20-2013Class III64675 cartonsPULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Suspension NDC: 0186-1989-04Terminated

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.