Bupropion Hydrochloride Tablet, Extended Release
FDA Recall NDC 60687-793
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 60687-793). A significant event, classified as Class II, was initiated on Jun 24, 2024 by American Health Packaging. The reported reason for this action was: "Failed Dissolution Specifications; the product is dissolving faster than the specified limits."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
June 2024 Class II Recall: Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Recall Number
Class II Ongoing
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Jun 24, 2024
Jul 17, 2024
2,484 cartons
Recall Profile & Regulatory Data
Event ID
94891
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amerisource Health Services LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 60687-782-01.
Batch or Lot Expiration Information
Lot# Lot 1017343, Exp. 12/31/2025
Affected Packages Involved in this Recall
60687-782-11Product
60687-782-01Product
60687-793-11Product
60687-793-21Product
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.
