D-1433-201 Class II Terminated
FDA drug recall D-1433-201 was initiated by Hospira Inc. on Jun 27, 2014 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing. The recall status is terminated (terminated Sep 9, 2015). Affected quantity: 47,400 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 23, 2014
- Initiation Date
- Jun 27, 2014
- Termination Date
- Sep 9, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 47,400 vials
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.
Reason for Recall
Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.
Distribution Pattern
U.S. Nationwide
Code Information
Lot #: 39474DK, Expiry: 03/01/2016.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1433-201
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026