TOPIC: Sterile Water for Injection USP by Hospira: Recall – Due to the Potential Presence of Visible Particulate
AUDIENCE: Health Professional, Risk Manager
ISSUE: Hospira is recalling lot DN9185 of Sterile Water for Injection USP, 100 mL Single Dose Glass Fliptop Vial due to a confirmed customer report for a single vial with a visible particulate.
Hospira’s assessment of the potential risk to patients concluded that in rare instances the use of the impacted product can be associated with potential adverse events such as anaphylaxis, fever, gastrointestinal disturbances, vein irritation, localized vein inflammation, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, and infarction.
To date, Hospira has not received reports of any adverse events associated with this issue for this lot.
For more information about this recall, click on the red button “Read Recall” below.
BACKGROUND: Sterile Water for Injection USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers. This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
RECOMMENDATIONS:
- Hospira has notified wholesalers/distributors/hospitals by letter to arrange for return of any recalled product.
- Hospitals with an existing inventory of the lot, which is being recalled, should stop use and distribution and quarantine immediately.
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