Rifampin Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 67457-445
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 Rifampin (NDC 67457-445). A significant event, classified as Class II, was initiated on Apr 07, 2022 by Mylan Institutional Llc. The reported reason for this action was: "Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing."
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
Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
Apr 07, 2022
Apr 27, 2022
33,893 vials
Recall Profile & Regulatory Data
Event ID
89910
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mylan Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
May 23, 2023
Product Description
Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., NDC 67457-445-60
Batch or Lot Expiration Information
Lot# : 7008990, exp. date Dec-2022; 7009025, exp. date Feb-2023; 7009085, 7009086, exp. date Apr-2023
Affected Packages Involved in this Recall
67457-445-60Product
October 2019 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product.
Oct 07, 2019
Oct 16, 2019
19,165 vials
Recall Profile & Regulatory Data
Event ID
83914
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mylan Laboratories Limited (Sterile Products Division)
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Mar 09, 2023
Product Description
Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60.
Batch or Lot Expiration Information
Lot# Lot: 7008334, Exp April 2020; 7008417, Exp Oct 2020
Affected Packages Involved in this Recall
67457-445-60Product
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.
