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Recall Observatory FDA recall evidence

Drug product

0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7985-09.

D-0286-2015

October 14, 2014

Class II

Product summary

Firm
Hospira Inc.
Event
Event 69494
Status
Terminated
Classification
Class II
Quantity
784,920 bags
Official record key
drug-enforcement:D-0286-2015

Official wording

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

Code information: Lot # 33-027-JT; Exp.09/15 Lot # 33-045-JT; Exp.09/15 Lot # 33-097-JT; Exp.09/15 Lot # 35-068-JT; Exp.11/15 Lot # 36-112-JT; Exp.12/15 Lot # 37-012-JT; Exp.01/15

Distribution pattern: Nationwide, Puerto Rico, and U.S. Virgin Islands.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility