Ceftriaxone Sodium Injection, Powder, For Solution
FDA Recall NDC 0409-7337
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 Ceftriaxone Sodium (NDC 0409-7337). A significant event, classified as Class III, was initiated on Oct 19, 2016 by Hospira, Inc. The reported reason for this action was: "Labeling: Missing Label"
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 III Terminated
Labeling: Missing Label
Oct 19, 2016
Nov 30, 2016
139,430 vials
Recall Profile & Regulatory Data
Event ID
75563
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Sandoz Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
WI
Termination Date
Jul 27, 2017
Product Description
Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM or I.V. Use, Manufactured by: Sandoz GMbH for Hospira Worldwide, Inc., Lake Forest, Il 60045, USA, Made in Austria, NDC 0409-7332-01
Batch or Lot Expiration Information
Lot# Sandoz - Lot GJ7151(Pfizer- Lot 670028M); Exp. 07/19
Affected Packages Involved in this Recall
0409-7337-11Product
0409-7337-01Product
0409-7338-11Product
0409-7338-01Product
0409-7332-11Product
0409-7332-01Product
0409-7335-13Product
0409-7335-03Product
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.
