Midazolam Injection, Solution
FDA Recall NDC 63323-412
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Midazolam (NDC 63323-412). A significant event, classified as Class II, was initiated on Dec 16, 2016 by Fresenius Kabi Usa, Llc. The reported reason for this action was: "Failed Impurities/Degradation Specifications"
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
December 2016 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications
Dec 16, 2016
Feb 08, 2017
47, 020 vials
Recall Profile & Regulatory Data
Event ID
76001
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Jun 22, 2018
Product Description
MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC 63323-412-05
Batch or Lot Expiration Information
Lot# Lot 6007327, exp. 01-2017; Lot 6007329, exp. 01-2017
Affected Packages Involved in this Recall
63323-411-22Product
63323-411-27Product
63323-411-15Product
63323-411-12Product
63323-411-18Product
63323-411-25Product
63323-411-13Product
63323-411-10Product
63323-412-18Product
63323-412-25Product
63323-412-03Product
63323-412-02Product
63323-412-06Product
63323-412-05Product
63323-412-13Product
63323-412-10Product
Class II Terminated
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Sep 27, 2012
Dec 17, 2014
101,200 Vials
Recall Profile & Regulatory Data
Event ID
63451
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide Including Puerto Rico
Termination Date
Dec 12, 2014
Product Description
MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Schaumburg, IL 60173. NDC: 63323-412-25.
Batch or Lot Expiration Information
Lot# Lot 6003827, Exp. Date 04/2015
Affected Packages Involved in this Recall
63323-411-22Product
63323-411-27Product
63323-411-15Product
63323-411-12Product
63323-411-18Product
63323-411-25Product
63323-411-13Product
63323-411-10Product
63323-412-18Product
63323-412-25Product
63323-412-03Product
63323-412-02Product
63323-412-06Product
63323-412-05Product
63323-412-13Product
63323-412-10Product
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.
