Fentanyl Citrate Injection, Solution
FDA Recall NDC 0409-9094
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Fentanyl Citrate (NDC 0409-9094). A significant event, classified as Class II, was initiated on Jul 20, 2020 by Hospira, Inc.. The reported reason for this action was: "Lack of Assurance of Sterility; potential loose metal overseal crimp defects."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
July 2020 Class II Recall: Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
Recall Number
Class II Terminated
Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
Jul 20, 2020
Aug 12, 2020
19,144 vials
Recall Profile & Regulatory Data
Event ID
86074
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States including Puerto Rico
Termination Date
Dec 08, 2022
Product Description
Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA NDC 0409-9094-12
Batch or Lot Expiration Information
Lot# Lots: Tray lot: 13405DK Vial lot: 13-405 DK Exp. 1JUL2021, Tray lot: 17096DK Vial lot: 17-096-DK Exp. 1NOV2021
Affected Packages Involved in this Recall
0409-9093-41Product
0409-9093-36Product
0409-9093-31Product
0409-9093-38Product
0409-9094-12Product
0409-9094-22Product
0409-9094-18Product
0409-9094-25Product
0409-9094-17Product
0409-9094-28Product
0409-9094-16Product
0409-9094-31Product
0409-9094-41Product
0409-9094-61Product
December 2014 Class II Recall: Lack of Assurance of Sterility; improperly crimped fliptop vials
Recall Number
Class II Terminated
Lack of Assurance of Sterility; improperly crimped fliptop vials
Dec 03, 2014
Dec 17, 2014
62,650 vials
Recall Profile & Regulatory Data
Event ID
69971
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Oct 02, 2015
Product Description
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
Affected Packages Involved in this Recall
0409-9093-41Product
0409-9093-36Product
0409-9093-31Product
0409-9093-38Product
0409-9094-12Product
0409-9094-22Product
0409-9094-18Product
0409-9094-25Product
0409-9094-17Product
0409-9094-28Product
0409-9094-16Product
0409-9094-31Product
0409-9094-41Product
0409-9094-61Product
Class II Terminated
Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.
Jun 27, 2014
Jul 23, 2014
47,400 vials
Recall Profile & Regulatory Data
Event ID
68751
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Termination Date
Sep 09, 2015
Product Description
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.
Affected Packages Involved in this Recall
0409-9093-41Product
0409-9093-36Product
0409-9093-31Product
0409-9093-38Product
0409-9094-12Product
0409-9094-22Product
0409-9094-18Product
0409-9094-25Product
0409-9094-17Product
0409-9094-28Product
0409-9094-16Product
0409-9094-31Product
0409-9094-41Product
0409-9094-61Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
