Hospira, Inc. is voluntarily recalling one lot of multi-dose bacteriostatic water after the company was unable to confirm sterilization for some vials from the lot in question. The product is used for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection in animals. The product was distributed in the U.S. and Puerto Rico to hospitals and retailers from March to April 2018.
Recalled Product
Bacteriostatic Water for Injection, USP, 30 mL, multi-dose vial is packaged as described below:
| NDC | Lot Number | Expiration Date | Presentation | Configuration/ Count |
|---|---|---|---|---|
| Vial: 0409-3977-01 Carton: 0409-3977-03 | W20308 | 01 DEC 2019 | 30 mL, Multiple dose | 4 x 25 x 30mL vials |
Hospira is notifying its direct customers via a recall letter to arrange for return of any recalled product. Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine immediately.
Risks to Patients
In the event that a non-sterile product is administered to a patient, there is an increased risk that severe adverse events may occur, such as:
- invasive bacterial infection, including bacterial meningitis and/or septicemia
- fever
- chills
- malaise
- cutaneous abscess
To date, Hospira has not received reports of any such adverse events associated with this product.
Contact Information
For clinical inquiries, please contact parent company Pfizer:
- For medical questions regarding this product: Call 1-800-438-1985, select option 3
- To report adverse events or product complaints: Call 1-800-438-1985, select option 1
—Source: Food & Drug Administration
