Hydralazine Hydrochloride Injection
FDA Recall NDC 63323-614
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 Hydralazine Hydrochloride (NDC 63323-614). A significant event, classified as Class II, was initiated on Mar 08, 2017 by Fresenius Kabi Usa, Llc. The reported reason for this action was: "Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation."
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
Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation.
Mar 08, 2017
Apr 19, 2017
98 vials
Recall Profile & Regulatory Data
Event ID
76863
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mckesson Medical Surgical
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Aug 19, 2024
Product Description
hydrALAZINE HYDROCHLORIDE INJECTION, USP, 20 mg/mL, 1 mL Single Dose Vial, packaged in 25 Vials per carton, Rx only, APP Fresenius Kabi USA, LLC, Lake Surich, IL 60047, NDC 63323-614-01, Distributed by McKesson Medical-Surgical, Inc.
Batch or Lot Expiration Information
Lot# s: 6114311, 6114717, Exp 05/18
Affected Packages Involved in this Recall
63323-614-00Product
63323-614-01Product
Class III Terminated
Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)
Jul 28, 2015
Aug 19, 2015
93,000 vials
Recall Profile & Regulatory Data
Event ID
71827
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 08, 2016
Product Description
Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius Kabi USA 2020 N Ruby Street, Melrose Park, IL 60160-1112 for Fresenius Kabi USA, 3 Corporate Dr Lake Zurich, IL 60047-8930. NDC 63323-614-01
Batch or Lot Expiration Information
Lot# : 6110593, Exp 11/2016
Affected Packages Involved in this Recall
63323-614-00Product
63323-614-01Product
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.
