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

FDA recall notice · announced March 19, 2014 · Pinnacle Biologics

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Reason for recall

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

Notes

Distribution: US: Nationwide and Taiwan
Lot/code information: Lot Number: 0M396; Expiry: Nov 2014
Quantity: 261 vials
Status: Terminated
Products in this recall event:
- 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 (D-1157-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.