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
Reported: November 27, 2013 Initiated: September 24, 2013 #D-013-2014
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.
Details
- Recalling Firm
- Hospira Inc.
- Units Affected
- 681,400 vials
- Distribution
- Nationwide and Puerto Rico
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Hospira Inc.. Units affected: 681,400 vials.
Why was this product recalled? ▼
Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 27, 2013. Severity: Moderate. Recall number: D-013-2014.
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