June 2014 FDA Recall Fentanyl Citrate by Hospira Inc.
D-1433-201 - Lack of Assurance of Sterility
This Class II drug recall was voluntarily initiated by Hospira Inc. on June 27, 2014 for the product Fentanyl Citrate. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1433-201
Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.
06-27-2014
07-23-2014
47,400 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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.
Hospira 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.
U.S. Nationwide
09-09-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only. Hospira, Inc., Lake Forest, IL 60045. NDC: 0409-9094-61.
Batch or Lot Expiration Information
Lot# : 39474DK, Expiry: 03/01/2016.
