# FDA recall D-1545-2022

> **CIPLA** · Class II · drug recall initiated 2022-09-15.

## Product

Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile Suspension, Manufactured by: Cipla Ltd., India, Manufactured for Cipla USA Inc., Warren NJ, NDC# 69097-318-86.

## Reason for recall

Lack of Assurance of Sterility

## Distribution

Nationwide in the USA and Puerto Rico

## Key facts

- **Recall number:** D-1545-2022
- **Recalling firm:** CIPLA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-09-15
- **Report date:** 2022-10-05
- **Termination date:** 2024-01-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warren, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1545-2022

## Citation

> AI Analytics. FDA recall D-1545-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-1545-2022. Source: US FDA. Licensed CC0.

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