# FDA recall D-1078-2015

> **Cipla Limited** · Class III · drug recall initiated 2015-04-24.

## Product

Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Indure, SEZ, Pithampur, M.P.-454 775, INDIA, Manufactured for: Dr. Reddy's Laboratories, Inc., Princeton NJ 08640.  NDC: 43598-412-25.

## Reason for recall

Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.

## Distribution

U.S. Nationwide including Puerto Rico.

## Key facts

- **Recall number:** D-1078-2015
- **Recalling firm:** Cipla Limited
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-04-24
- **Report date:** 2015-05-20
- **Termination date:** 2017-02-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pithampur, District Dhar, N/A, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1078-2015

## Citation

> AI Analytics. FDA recall D-1078-2015. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1078-2015. Source: US FDA. Licensed CC0.

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