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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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Product Detail

Product Description 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
Recall Number D-1157-2014
Classification Class III
Code Info Lot Number: 0M396; Expiry: Nov 2014
Product Distributed Qty 261 vials
Reason For Recall Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014.

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 Letter
Distribution Pattern US: Nationwide and Taiwan