Rifampin Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 63323-351
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 Rifampin (NDC 63323-351). A significant event, classified as Class II, was initiated on Jun 04, 2015 by Fresenius Kabi Usa, Llc. The reported reason for this action was: "Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation"
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
June 2015 Class II Recall: Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation
Jun 04, 2015
Jul 22, 2015
7,593 vials
Recall Profile & Regulatory Data
Event ID
71409
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide,Hawaii, and Puerto Rico
Termination Date
May 19, 2016
Product Description
Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, Lake Zurich, IL, 60047, by Fresenius Kabi LLC, 2020 N Ruby Street, Melrose Park, IL 60160. NDC 63323-351-20
Batch or Lot Expiration Information
Lot# : 6109469, 6109470, Exp 10/2016
Affected Packages Involved in this Recall
63323-351-20Product
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.
