Recalls / Class III
Class IIID-1157-2014
Product
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
- Brand name
- Photofrin
- Generic name
- Porfimer Sodium
- Active ingredient
- Porfimer Sodium
- Route
- Intravenous
- NDC
- 76128-155
- FDA application
- NDA020451
- Affected lot / code info
- Lot Number: 0M396; Expiry: Nov 2014
Why it was recalled
Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014.
Recalling firm
- Firm
- Pinnacle Biologics Inc
- Manufacturer
- Pinnacle Biologics, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2801 Lakeside Dr Ste 209, N/A, Bannockburn, Illinois 60015-1271
Distribution
- Quantity
- 261 vials
- Distribution pattern
- US: Nationwide and Taiwan
Timeline
- Recall initiated
- 2014-02-10
- FDA classified
- 2014-03-12
- Posted by FDA
- 2014-03-19
- Terminated
- 2015-05-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1157-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.