FDA recall D-1177-2017

Product

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

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2017-09-01

Report date

2017-10-04

Termination date

2020-01-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1177-2017