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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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Event Detail

Event ID 67688
Product Type Drugs
Status Ongoing
Recalling Firm Pinnacle Biologics Inc
City Bannockburn
State IL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-02-10
Initial Firm Notification of
Consignee or Public
Distribution Pattern US: Nationwide and Taiwan

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Photofrin (porfimer sodium) for Injection, 75 mg Single Use Flip-Top Vial, Rx Only. Manufactured for: Pinnacle Biologics, Inc. Bannockburn, IL 60015. NDC:76128-155-75 Lot Number: 0M396; Expiry: Nov 2014 Class III Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014. 261 vials D-1157-2014