Clobazam Tablet
FDA Recall NDC 60687-423
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 Clobazam (NDC 60687-423). A significant event, classified as Class II, was initiated on Jan 07, 2025 by American Health Packaging. The reported reason for this action was: "Presence of Foreign Tablets/Capsules"
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
Class II Ongoing
Presence of Foreign Tablets/Capsules
Jan 07, 2025
Jan 22, 2025
4640 units
Recall Profile & Regulatory Data
Event ID
96117
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amerisource Health Services LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-11
Batch or Lot Expiration Information
Lot# : 1018598, Exp. Date 10/31/2025
Affected Packages Involved in this Recall
60687-423-11Product
60687-423-21Product
Class II Ongoing
Presence of Foreign Tablets/Capsules
Dec 13, 2024
Jan 15, 2025
5,178 cartons
Recall Profile & Regulatory Data
Event ID
96017
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amerisource Health Services LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-21
Batch or Lot Expiration Information
Lot# : 1019594, Exp. Date 12/31/2025
Affected Packages Involved in this Recall
60687-423-11Product
60687-423-21Product
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.
