Drug Enforcement D-316-2013

Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.

Status

Terminated

Classification

Class II

Report Date

May 15, 2013

Termination Date

November 10, 2014

Product Information

Product description
Sodium Acetate Injection, USP, 40 mEq/20 ml (2 mEq/mL) 20 mL Single-Dose Fliptop, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-7299-73
Product quantity
266,900 vials
Reason for recall
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide and Puerto Rico

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-316-2013
Event ID
65077
Recall initiation date
February 26, 2013
Center classification date
May 6, 2013
Code info
Lot 23-320-DK and 23-321-DK Exp. 11/14
More code info
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