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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Product Detail

Product Description Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intravenous Use Only, Manufactured by PETNET Solutions, Inc., Knoxville, TN
Recall Number D-579-2013
Classification Class II
Code Info Batch # BN-3350 Rx #s: [38126044] [38126058] [38126059] [38126021] [38126022] [38126023] [38125981] [38125991] [38125992] [38126016] [38126017] [38126004] [38126005] [38126006] [38126007] [38126057] [38125999] [38126036] [38126037] [38126038] [38125998] [38126033]
Product Distributed Qty 28 doses
Reason For Recall cGMP Deviation

Event Detail

Event Id 64635
Product Type Drugs
Status Terminated
Recalling Firm Petnet Solution Inc
City Irvine
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-22
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Within the state of CA.
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