Drug 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
D-1157-2014
Product summary
- Event
- Event 67688
- Status
- Terminated
- Classification
- Class III
- Quantity
- 261 vials
- Official record key
drug-enforcement:D-1157-2014
Official wording
Reason: Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014.
Code information: Lot Number: 0M396; Expiry: Nov 2014
Distribution pattern: US: Nationwide and Taiwan
Derived failure modes
-
Potency or specification failure
Stability Data Does Not Support Expiry