Clobazam Suspension
FDA Recall NDC 69452-116
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 Clobazam (NDC 69452-116). A significant event, classified as Class II, was initiated on Jul 16, 2019 by Bionpharma Inc.. The reported reason for this action was: "Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed."
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
July 2019 Class II Recall: Microbial Contamination of Non-Sterile Products
Recall Number
Class II Terminated
Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.
Jul 16, 2019
Jul 31, 2019
3,020 bottles
Recall Profile & Regulatory Data
Event ID
83356
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Bionpharma Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Mar 05, 2020
Product Description
Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only, Distributed by: Bionpharma Inc., 600 Alexander Road, Princeton, NJ 08540, NDC 69452-116-45.
Batch or Lot Expiration Information
Lot# : 18246, Exp 09/2020
Affected Packages Involved in this Recall
69452-116-45Product
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.
