PlainRecalls
FDA Drug Moderate Class II Terminated

Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, NDC Carton: 0409-4887-99; NDC Vial: 0409-4887-25

Reported: May 26, 2021 Initiated: May 3, 2021 #D-0384-2021

Product Description

Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, NDC Carton: 0409-4887-99; NDC Vial: 0409-4887-25

Reason for Recall

Presence of Particulate Matter: particulate matter identified as an insect in one vial.

Details

Recalling Firm
Pfizer Inc.
Units Affected
49,525 vials
Distribution
Nationwide USA
Location
New York, NY

Frequently Asked Questions

What product was recalled?
Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, NDC Carton: 0409-4887-99; NDC Vial: 0409-4887-25. Recalled by Pfizer Inc.. Units affected: 49,525 vials.
Why was this product recalled?
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 26, 2021. Severity: Moderate. Recall number: D-0384-2021.