FDA recall D-1852-2019

Product

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

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide US and Puerto Rico

Key facts

Status

Terminated

Initiation date

2019-09-06

Report date

2019-09-18

Termination date

2023-03-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1852-2019