Bupropion Tablet, Extended Release
FDA Recall NDC 68382-353
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 Bupropion (NDC 68382-353). A significant event, classified as Class III, was initiated on Nov 02, 2016 by Zydus Pharmaceuticals Usa Inc.. The reported reason for this action was: "Failed Dissolution Specifications; 6 month time point"
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
November 2016 Class III Recall: Failed Dissolution Specifications; 6 month time point
Recall Number
Class III Terminated
Failed Dissolution Specifications; 6 month time point
Nov 02, 2016
Dec 28, 2016
16,356 bottles
Recall Profile & Regulatory Data
Event ID
75764
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jul 23, 2020
Product Description
BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534
Batch or Lot Expiration Information
Lot# a) MS1667 exp 01/2018; M601708, exp 03/2018; b) MS1667, MS1668, MS1669, exp 01/2018; M601515, M601516, exp 03/2018; M602920, M602921, M605399, M602937, M602938, M602939, exp 04/2018; M603988, exp 06/2018
Affected Packages Involved in this Recall
68382-354-06Product
68382-354-16Product
68382-354-05Product
68382-354-10Product
68382-353-06Product
68382-353-16Product
68382-353-05Product
68382-353-10Product
Class III Terminated
Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
Aug 03, 2016
Nov 30, 2016
2,472 units
Recall Profile & Regulatory Data
Event ID
75696
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jul 12, 2018
Product Description
BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA inc. Pennington, NJ 08534, NDC 68382-354-05
Batch or Lot Expiration Information
Lot# : MR3365, Exp. Feb 17
Affected Packages Involved in this Recall
68382-354-06Product
68382-354-16Product
68382-354-05Product
68382-354-10Product
68382-353-06Product
68382-353-16Product
68382-353-05Product
68382-353-10Product
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.
