Status
Terminated
Drug Enforcement D-013-2014
Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
Classification
Class II
Report Date
November 27, 2013
Termination Date
October 6, 2014
Product Information
- 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
- Product quantity
- 681,400 vials
- Reason for recall
- Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Hospira Inc.
- Address
-
275 N Field Dr
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-013-2014
- Event ID
- 66422
- Recall initiation date
- September 24, 2013
- Center classification date
- November 20, 2013
- Code info
- 29-484-DK* and 29-510-DK* Exp 05/01/2015 (lot number may be proceeded with an 01)
- More code info
- —