Bacteriostatic Water Injection, Solution
FDA Recall NDC 0409-3977
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 Bacteriostatic Water (NDC 0409-3977). A significant event, classified as Class II, was initiated on Sep 06, 2019 by Hospira, Inc.. The reported reason for this action was: "Lack of Assurance of Sterility"
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
Lack of Assurance of Sterility
Sep 06, 2019
Sep 18, 2019
185,700 vials
Recall Profile & Regulatory Data
Event ID
83699
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide US and Puerto Rico
Termination Date
Mar 25, 2023
Product Description
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
Batch or Lot Expiration Information
Lot# : W20308, Exp. Dec 1, 2019
Affected Packages Involved in this Recall
0409-3977-01Product
0409-3977-03Product
0409-1093-14Product
0409-1093-04Product
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.
