Class II · Moderate riskTerminated Initiated Sep 24, 2013 (13 years ago)
Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
What 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
Recalling firm
Hospira Inc.
NDC code
0409-4755-03
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-013-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and…
Reason Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and…