Drug Enforcement D-381-2014

Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.

Status

Terminated

Classification

Class I

Report Date

December 25, 2013

Termination Date

February 3, 2015

Product Information

Product description
0.75% Bupivacaine HCl Injection, USP, 7.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1165-02
Product quantity
119,600 vials
Reason for recall
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
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-381-2014
Event ID
66260
Recall initiation date
July 12, 2013
Center classification date
December 18, 2013
Code info
Lot # 23-338-DK, Exp. 11/14
More code info
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