Bacteriostatic Water for Injection recalled over sterility concerns

Recall date

September 6, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Pfizer Inc. recalls Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hospira, Inc., Lake Forest, IL 60045 USA. NDC…

Recall number

D-1852-2019

FDA classification

Class II

Brand / firm

Pfizer Inc.

Sold / distributed

Nationwide US and Puerto Rico

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hospira, Inc., Lake Forest, IL 60045 USA. NDC Vial: 0409-3977-01; NDC Carton: 0409-3977-03