Bupropion Hydrochloride Tablet, Film Coated
FDA Recall NDC 60687-340
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 Bupropion Hydrochloride (NDC 60687-340). A significant event, classified as Class II, was initiated on Dec 27, 2022 by American Health Packaging. The reported reason for this action was: "Failed Impurities/Degradation Specifications"
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
December 2022 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications
Dec 27, 2022
Feb 22, 2023
1,416 cartons
Recall Profile & Regulatory Data
Event ID
91609
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Amerisource Health Services LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the USA
Termination Date
Aug 04, 2023
Product Description
BuPROPion Hydrochloride Tablets, USP 75 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-340-01; NDC Blister Pack: 60687-340-11
Batch or Lot Expiration Information
Lot# : 1003837, Exp. Date 01/31/2023
Affected Packages Involved in this Recall
60687-340-11Product
60687-340-01Product
60687-351-11Product
60687-351-01Product
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.
