D-013-2014 Class II Terminated
FDA drug recall D-013-2014 was initiated by Hospira Inc. on Sep 24, 2013 and is designated Class II. Reason for recall: Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials. The recall status is terminated (terminated Oct 6, 2014). Affected quantity: 681,400 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 27, 2013
- Initiation Date
- Sep 24, 2013
- Termination Date
- Oct 6, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 681,400 vials
Product Description
Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest IL 60045, USA, NDC 0409-4755-03
Reason for Recall
Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
29-484-DK* and 29-510-DK* Exp 05/01/2015 (lot number may be proceeded with an 01)
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-013-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026