February 2014 FDA Recall Photofrin by Pinnacle Biologics Inc
D-1157-2014 - Stability Data Does Not Support Expiry
This Class III drug recall was voluntarily initiated by Pinnacle Biologics Inc on February 10, 2014 for the product Photofrin. The FDA reported the reason for recall as stability data does not support expiry. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1157-2014
Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014.
02-10-2014
03-19-2014
261 vials
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pinnacle Biologics Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US: Nationwide and Taiwan
05-22-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of 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
Batch or Lot Expiration Information
Lot# Lot Number: 0M396; Expiry: Nov 2014
