D-395-2014 Class II Terminated
FDA drug recall D-395-2014 was initiated by Hospira Inc. on Oct 11, 2013 and is designated Class II. Reason for recall: Lack of assurance of sterility; equipment failure led to potential breach in asceptic process. The recall status is terminated (terminated Nov 10, 2014). Affected quantity: 65109 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 8, 2014
- Initiation Date
- Oct 11, 2013
- Termination Date
- Nov 10, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 65109 vials
Product Description
0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045. NDC #0409-9046-01.
Reason for Recall
Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
Distribution Pattern
US Nationwide.
Code Information
Lot #32-484-EV, 32-485-EV Exp: 2/2015.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-395-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026