Drug product
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
D-013-2014
Product summary
- Firm
- Hospira Inc.
- Event
- Event 66422
- Status
- Terminated
- Classification
- Class II
- Quantity
- 681,400 vials
- Official record key
drug-enforcement:D-013-2014
Official wording
Reason: Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
Code information: 29-484-DK* and 29-510-DK* Exp 05/01/2015 (lot number may be proceeded with an 01)
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Unknown
Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.