FDA recall D-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

Reason for recall

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

Distribution

US: Nationwide and Taiwan

Key facts

Status

Terminated

Initiation date

2014-02-10

Report date

2014-03-19

Termination date

2015-05-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bannockburn, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1157-2014