Cyanocobalamin Injection, Solution
FDA Recall NDC 63323-044
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 Cyanocobalamin (NDC 63323-044). A significant event, classified as Class II, was initiated on Sep 27, 2012 by Fresenius Kabi Usa, Llc. The reported reason for this action was: "Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles."
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: Glass vials may have finish fractures and glass particles.
Sep 27, 2012
Dec 17, 2014
240,550 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
CYANOCOBALAMIN INJECTION, USP, 1000 mcg/mL, For IM or IV Use, Multiple Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-044-01.
Batch or Lot Expiration Information
Lot# Lot 6003853, exp. date 04/2014
Affected Packages Involved in this Recall
63323-044-00Product
63323-044-01Product
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.
