D-1157-2014 Class III Terminated
FDA drug recall D-1157-2014 was initiated by Pinnacle Biologics Inc on February 10, 2014 and is designated Class III. Reason for recall: Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014. The recall status is terminated (terminated May 22, 2015). Affected quantity: 261 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- March 19, 2014
- Initiation Date
- February 10, 2014
- Termination Date
- May 22, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 261 vials
Product Description
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 Pattern
US: Nationwide and Taiwan
Code Information
Lot Number: 0M396; Expiry: Nov 2014