Reported Mar 19, 2014 · Terminated

Photofrin (porfimer sodium) for Injection, 75 mg Single Use Flip-Top Vial, Rx Only. Manufactured for: Pinnacle…

Pinnacle Biologics Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Pinnacle Biologics Inc · 2801 Lakeside Dr Ste 209 · Bannockburn, IL · 60015-1271

Is this the product you have?

  • Photofrin (porfimer sodium) for Injection, 75 mg Single Use Flip-Top Vial, Rx Only
  • Manufactured forPinnacle Biologics, Inc. Bannockburn, IL 60015
  • NDC76128-155-75
Lot codes and dates
  • Lot Number0M396
  • ExpiryNov 2014
Amount recalled
261 vials

Where it was sold

  • Nationwide

Why it was recalled

Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated May 22, 2015 · Data as of Sep 19, 7:20 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.