# FDA recall D-1378-2012

> **Luitpold Pharmaceuticals, Inc.** · Class II · drug recall initiated 2011-03-15.

## Product

CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4%  a) 30 mL SINGLE DOSE VIAL,  (NDC 0517-2930-25), b) 100 mL PHARMACY BULK PACKAGE (NDC 0517-2900-25), Rx Only, AMERICAN REGENT, INC. SHIRLEY, NY 11967.

## Reason for recall

Presence of Particulate Matter:  In the course of inspecting retention samples visual particles were observed.

## Distribution

Nationwide, Puerto Rico, and Abu Dhabi

## Key facts

- **Recall number:** D-1378-2012
- **Recalling firm:** Luitpold Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2011-03-15
- **Report date:** 2012-06-20
- **Termination date:** 2018-06-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Shirley, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1378-2012

## Citation

> AI Analytics. FDA recall D-1378-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1378-2012. Source: US FDA. Licensed CC0.

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