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Recall Observatory FDA recall evidence

Drug product

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

D-0285-2015

October 14, 2014

Class II

Product summary

Firm
Hospira Inc.
Event
Event 69494
Status
Terminated
Classification
Class II
Quantity
16,487,040 bags
Official record key
drug-enforcement:D-0285-2015

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 # 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

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