Photofrin Injection, Powder, For Solution
FDA Recall NDC 76128-155
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Photofrin (NDC 76128-155). A significant event, classified as Class III, was initiated on Feb 10, 2014 by Pinnacle Biologics, Inc.. The reported reason for this action was: "Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014.
Feb 10, 2014
Mar 19, 2014
261 vials
Recall Profile & Regulatory Data
Event ID
67688
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Pinnacle Biologics Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US: Nationwide and Taiwan
Termination Date
May 22, 2015
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
Batch or Lot Expiration Information
Lot# Lot Number: 0M396; Expiry: Nov 2014
Affected Packages Involved in this Recall
76128-155-75Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
