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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Product Detail

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
Recall Number D-381-2014
Classification Class I
Code Info Lot # 23-338-DK, Exp. 11/14
Product Distributed Qty 119,600 vials
Reason For Recall Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.

Event Detail

Event Id 66260
Product Type Drugs
Status Ongoing
Recalling Firm Hospira Inc.
City Lake Forest
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-12
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide