Diazepam Injection, Solution
FDA Recall NDC 0409-1273
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 Diazepam (NDC 0409-1273). A significant event, classified as Class II, was initiated on Jun 23, 2016 by Hospira, Inc.. The reported reason for this action was: "Crystallization: Product contains particulate identified to be crystallized active ingredient."
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
Crystallization: Product contains particulate identified to be crystallized active ingredient.
Jun 23, 2016
Jul 20, 2016
373,850 tubes
Recall Profile & Regulatory Data
Event ID
74399
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Aug 31, 2018
Product Description
Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake Forest, IL 60045, NDC 0409-1273-32
Batch or Lot Expiration Information
Lot# : 52610LL, Exp. 01 OCT 2016
Lot# : 57660LL, Exp. 01 MAR 2017
Affected Packages Involved in this Recall
0409-1273-03Product
0409-1273-32Product
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.
