D-0294-2015 Class II Terminated
FDA drug recall D-0294-2015 was initiated by Hospira Inc. on Dec 3, 2014 and is designated Class II. Reason for recall: Lack of Assurance of Sterility; improperly crimped fliptop vials The recall status is terminated (terminated Oct 2, 2015). Affected quantity: 62,650 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 17, 2014
- Initiation Date
- Dec 3, 2014
- Termination Date
- Oct 2, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 62,650 vials
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
Reason for Recall
Lack of Assurance of Sterility; improperly crimped fliptop vials
Distribution Pattern
Nationwide
Code Information
Lot 41-099-DK, exp 01MAY2016, NDC 0409-9094-61
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0294-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026