Drug Enforcement D-176-2013

Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the primary container.

Status

Terminated

Classification

Class II

Report Date

March 6, 2013

Termination Date

April 24, 2015

Product Information

Product description
0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08
Product quantity
56,854 Units
Reason for recall
Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the primary container.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Hospira Inc.
Address
275 N Field Dr, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-176-2013
Event ID
64441
Recall initiation date
February 12, 2013
Center classification date
February 28, 2013
Code info
Lot 13-121-JT* * the lot number may be followed by 01
More code info
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