RecallRadar

FDA Drug recall D-243-2013

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

On 2013-04-10 the FDA classified a Class II recall of 0.9% Sodium Chloride Injection, USP, 50 mL, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7984-36 Hospira, Inc., Lake Fore… by Hospira, citing 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 th….

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-243-2013
ClassificationClass II
Statusterminated
Initiated2013-02-18
Published2013-04-10
Last updated2026-09-13 11:51 UTC
CompanyHospira
DistributionUS

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

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.

Identifiers

code_infoLot #: 22-028-JT Exp 04/14

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-243-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.