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

FDA recall notice · announced November 27, 2013 · Hospira

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: 29-484-DK* and 29-510-DK* Exp 05/01/2015 (lot number may be proceeded with an 01)
Quantity: 681,400 vials
Status: Terminated
Products in this recall event:
- Metoclopramide Injection, USP 10 mg (5mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-3414-01 (D-012-2014)
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.