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Hospira, Inc., Issues A Voluntary Nationwide Recall for one lot of BACTERIOSTATIC WATER for Injection, USP, due to a Potential Lack of Sterility Assurance

Last updated March 1, 2020

Approved by: Krish Tangella MD, MBA, FCAP

Hospira, Inc., a Pfizer company, is voluntarily recalling BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial, lot W20308, to the Hospital/Retail level. Hospira initiated this recall due to lack of confirmation of sterilization for some vials from this lot.


Company Announcement Date: September 06, 2019

FDA Publish Date: September 06, 2019

Product Type: Animal & Veterinary

Drugs

Reason for Announcement: Potential Lack of Sterility Assurance

Company Name: Hospira Inc.

Brand Name: Hospira Inc.

Product Description: Bacteriostatic Water for Injection

Hospira, Inc., a Pfizer company, is voluntarily recalling BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial, lot W20308, to the Hospital/Retail level. Hospira initiated this recall due to lack of confirmation of sterilization for some vials from this lot.

In the event that impacted product is administered to a patient, there is an increased risk that severe adverse events such as invasive bacterial infection, including bacterial meningitis, septicemia, and limited adverse events such as fever, chills, malaise, and cutaneous abscess may occur. To date, Hospira has not received reports of any such adverse events associated with this issue for this lot.

BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) of benzyl alcohol added as a bacteriostatic preservative. It 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.

BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial is packaged as described below. Product was distributed in the U.S. and Puerto Rico to Hospitals/Retailers from March 2018, to April 2018.

Hospira, Inc., places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. 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. Inform Healthcare Professionals in your organization of this recall. For additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.

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Reviewed and Approved by a member of the DoveMed Editorial Board
First uploaded: March 1, 2020
Last updated: March 1, 2020