# FDA recall D-199-2013

> **AstraZeneca LP** · Class III · drug recall initiated 2013-01-11.

## Product

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.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-199-2013
- **Recalling firm:** AstraZeneca LP
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-01-11
- **Report date:** 2013-03-20
- **Termination date:** 2013-07-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Westborough, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-199-2013

## Citation

> AI Analytics. FDA recall D-199-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-199-2013. Source: US FDA. Licensed CC0.

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