Sodium Acetate Injection, Solution, Concentrate
FDA Recall NDC 0409-7299
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 Sodium Acetate (NDC 0409-7299). A significant event, classified as Class II, was initiated on Feb 26, 2013 by Hospira, Inc.. The reported reason for this action was: "Lack of Assurance of Sterility: Loose crimp applied to the fliptop 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
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Feb 26, 2013
May 15, 2013
266,900 vials
Recall Profile & Regulatory Data
Event ID
65077
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Nov 10, 2014
Product Description
Sodium Acetate Injection, USP, 40 mEq/20 ml (2 mEq/mL) 20 mL Single-Dose Fliptop, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-7299-73
Batch or Lot Expiration Information
Lot# Lot 23-320-DK and 23-321-DK Exp. 11/14
Affected Packages Involved in this Recall
0409-7299-83Product
0409-7299-73Product
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.
