FDA-Drug2019-09-18Class II

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

Pfizer Inc.
Hazard

Lack of Assurance of Sterility

Sold states
Nationwide US and Puerto Rico
Affected count
185,700 vials
Manufactured in
235 E 42nd St, New York, NY, United States
Products
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

Official notice

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

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