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U.S. Department of Health and Human Services

Enforcement Report - Week of April 16, 2014

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Product Detail

Product Description Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
Recall Number D-1218-2014
Classification Class II
Code Info Lot #: 117456@3 Expiration Date: 12/12/2013 Lot #: 117907@3 Expiration Date: 12/19/2013 Lot #: 118297@8 Expiration Date: 12/25/2013
Product Distributed Qty 60 units
Reason For Recall Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.

Event Detail

Event Id 67080
Product Type Drugs
Status Ongoing
Recalling Firm Zions RX Formulations Services LLC dba RX Formuations Serv.
City Mesa
State AZ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-12-12
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern AZ