D-66295-001 Class II Terminated
FDA drug recall D-66295-001 was initiated by Hospira Inc. on Sep 5, 2013 and is designated Class II. Reason for recall: Lack of Assurance of Sterility; potential for vial breakage The recall status is terminated (terminated Oct 28, 2014). Affected quantity: 187,150 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 16, 2013
- Initiation Date
- Sep 5, 2013
- Termination Date
- Oct 28, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 187,150 vials
Product Description
0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial, NDC 0409-9045-01, Hospira, Inc., Lake Forest, IL 60045
Reason for Recall
Lack of Assurance of Sterility; potential for vial breakage
Distribution Pattern
Nationwide and Guam and Abu Dhabi
Code Information
Lot 17-400-EV* and 17-401-EV * Note: the lot number may be followed by 01
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-66295-001
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026