Sterile Water Injection
FDA Recall NDC 0409-4887
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Sterile Water (NDC 0409-4887). A significant event, classified as Class II, was initiated on May 03, 2021 by Hospira, Inc.. The reported reason for this action was: "Presence of Particulate Matter: particulate matter identified as an insect in one vial."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
May 03, 2021
May 26, 2021
49,525 vials
Recall Profile & Regulatory Data
Event ID
87831
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Termination Date
Jul 29, 2023
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
Batch or Lot Expiration Information
Lot# Lot DN9185
Affected Packages Involved in this Recall
0409-4887-25Product
0409-4887-99Product
0409-4887-31Product
0409-4887-05Product
0409-4887-17Product
0409-4887-10Product
0409-4887-32Product
0409-4887-34Product
0409-4887-23Product
0409-4887-20Product
0409-4887-24Product
0409-4887-50Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
