FDA recall D-243-2013

Hospira Inc. · Class II · drug

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

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

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