# FDA recall D-66462-001

> **Nephron Pharmaceuticals Corp.** · Class II · drug recall initiated 2013-10-02.

## Product

Albuterol Sulfate Inhalation Solution, 0.083%  2.5 mg/3 mL for Oral Inhalation Only, Rx Only, 25 x 3 mL Sterile Unit-Dose Vials per carton, Manufactured By: Nephron Pharmaceuticals Corporation, Orlando, FL 32811, NDC 0487-9501-25

## Reason for recall

Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-66462-001
- **Recalling firm:** Nephron Pharmaceuticals Corp.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-10-02
- **Report date:** 2013-10-30
- **Termination date:** 2015-08-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Orlando, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-66462-001

## Citation

> AI Analytics. FDA recall D-66462-001. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/D-66462-001. Source: US FDA. Licensed CC0.

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