# FDA recall D-0010-2016

> **Nephron Pharmaceuticals Corp.** · Class II · drug recall initiated 2015-08-21.

## Product

Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials, a) 30 count (NDC 0487-0201-03) and b) 60 count (NDC 0487-0201-60) vials per carton, Rx only, Nephron Pharmaceutical Corporation, Orlando, FL

## Reason for recall

Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0010-2016
- **Recalling firm:** Nephron Pharmaceuticals Corp.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-08-21
- **Report date:** 2015-10-21
- **Termination date:** 2017-02-10

- **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-0010-2016

## Citation

> AI Analytics. FDA recall D-0010-2016. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0010-2016. Source: US FDA. Licensed CC0.

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