Drug Enforcement D-309-2013

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

Status

Terminated

Classification

Class II

Report Date

May 8, 2013

Termination Date

September 18, 2014

Product Information

Product description
Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12
Product quantity
172,350 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

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

Codes & Dates

Recall number
D-309-2013
Event ID
64720
Recall initiation date
August 28, 2012
Center classification date
May 1, 2013
Code info
Lot 17-100-EV and 17-399-EV
More code info
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