December 2014 FDA Recall Fentanyl Citrate by Hospira Inc.
D-0294-2015 - Lack of Assurance of Sterility; improperly crimped fliptop vials
This Class II drug recall was voluntarily initiated by Hospira Inc. on December 3, 2014 for the product Fentanyl Citrate. The FDA reported the reason for recall as lack of assurance of sterility; improperly crimped fliptop vials. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0294-2015
Lack of Assurance of Sterility; improperly crimped fliptop vials
12-03-2014
12-17-2014
62,650 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.
Nationwide
10-02-2015
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, 50 mL Single-dose Flip top Vial (C-II), Rx only, 25 units per box/50 units per case, Hospira Inc., Lake Forest, IL --- NDC 0409-9094-61
Batch or Lot Expiration Information
Lot# Lot 41-099-DK, exp 01MAY2016, NDC 0409-9094-61
