RecallRadar

FDA Drug recall D-0285-2015

0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09

On 2014-12-03 the FDA classified a Class II recall of 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09 by Hospira, citing lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0285-2015
ClassificationClass II
Statusterminated
Initiated2014-10-14
Published2014-12-03
Last updated2026-09-13 11:51 UTC
CompanyHospira
DistributionUS

Product

0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.

Reason

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Identifiers

code_info
Lot # 32-044-JT; Exp. 08/15 Lot # 32-072-JT; Exp. 08/15 Lot # 32-102-JT; Exp. 08/15 Lot # 33-028-JT; Exp. 09/15 Lot…Lot # 32-044-JT; Exp. 08/15 Lot # 32-072-JT; Exp. 08/15 Lot # 32-102-JT; Exp. 08/15 Lot # 33-028-JT; Exp. 09/15 Lot # 33-046-JT; Exp. 09/15 Lot # 33-049-JT; Exp. 09/15 Lot # 33-061-JT; Exp. 09/15 Lot # 33-085-JT; Exp. 09/15 Lot # 33-096-JT; Exp. 09/15 Lot # 33-101-JT; Exp. 09/15 Lot # 33-102-JT; Exp. 09/15 Lot # 34-016-JT; Exp. 10/15 Lot # 34-085-JT; Exp. 10/15 Lot # 34-122-JT; Exp. 10/15 Lot # 34-123-JT; Exp. 10/15 Lot # 35-026-JT; Exp. 11/15 Lot # 35-030-JT; Exp. 11/15 Lot # 35-067-JT; Exp. 11/15 Lot # 36-002-JT ;Exp. 12/15 Lot # 36-029-JT; Exp. 12/15 Lot # 36-049-JT; Exp. 12/15 Lot # 36-058-JT; Exp. 12/15 Lot # 36-103-JT; Exp. 12/15 Lot # 37-013-JT; Exp. 01/16

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-0285-2015%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.