Rifampin Capsule
FDA Recall NDC 60687-586
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 60687-586). A significant event, classified as Class II, was initiated on Jan 11, 2024 by American Health Packaging. The reported reason for this action was: "Failed Impurities/Degradation Specification."
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
January 2024 Class II Recall: Failed Impurities/Degradation Specification.
Recall Number
Class II Terminated
Failed Impurities/Degradation Specification.
Jan 11, 2024
Feb 07, 2024
1,568 cartons
Recall Profile & Regulatory Data
Event ID
93851
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Amerisource Health Services LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Sep 30, 2024
Product Description
Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-575-21; NDC Unit Dose: 60687-575-11
Batch or Lot Expiration Information
Lot# : 1008111, Exp. Date 01/31/2024
Affected Packages Involved in this Recall
60687-586-11Product
60687-586-01Product
60687-575-11Product
60687-575-21Product
December 2022 Class II Recall: Failed Impurities/Degradations Specifications
Recall Number
Class II Terminated
Failed Impurities/Degradations Specifications
Dec 20, 2022
Jan 25, 2023
3,091 cartons
Recall Profile & Regulatory Data
Event ID
91416
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Amerisource Health Services LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Sep 06, 2024
Product Description
Rifampin Capsules USP, 300 mg, 100 Capsules (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 60687-586-01 (Individual Dose NDC: 60687-586-11)
Batch or Lot Expiration Information
Lot# : 1007805, exp. 12/31/2023
Affected Packages Involved in this Recall
60687-586-11Product
60687-586-01Product
60687-575-11Product
60687-575-21Product
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.
