Sterile Water for Injection recalled over sterility concerns

Recall date

September 1, 2017

Source

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

Official notice title

Pfizer Inc. recalls Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 6004…

Recall number

D-1177-2017

FDA classification

Class II

Brand / firm

Pfizer Inc.

Sold / distributed

Nationwide in the USA

Why it was recalled

Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.

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

What was recalled

Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 USA for Genentech, Inc., South San Francisco, CA 94080-4990. NDC 50242-901-24