# FDA recall D-243-2013

> **Hospira Inc.** · Class II · drug recall initiated 2013-02-18.

## Product

0.9% Sodium Chloride Injection, USP, 50 mL, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7984-36    Hospira, Inc., Lake Forest, IL 60045

## Reason for recall

Lack of Assurance of Sterility: The product is being recall due to the product lot being incorrectly released without meeting product specifications. There is the potential for the solution to leak from the administrative port to the fill tube seal.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-243-2013
- **Recalling firm:** Hospira Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-02-18
- **Report date:** 2013-04-10
- **Termination date:** 2015-04-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Forest, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-243-2013

## Citation

> AI Analytics. FDA recall D-243-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-243-2013. Source: US FDA. Licensed CC0.

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