Clobazam Tablet
FDA Recall NDC 42571-315
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 42571-315). A significant event, classified as Class II, was initiated on Feb 12, 2024 by Micro Labs Limited. The reported reason for this action was: "CGMP Deviations: Out of specification for residual solvents."
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
CGMP Deviations: Out of specification for residual solvents.
Feb 12, 2024
Feb 28, 2024
24,768 bottles
Recall Profile & Regulatory Data
Event ID
93975
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Micro Labs Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs Limited Goa-403 722, India. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873. NDC 42571-315-01
Batch or Lot Expiration Information
Lot# ZOAG043
Affected Packages Involved in this Recall
42571-315-30Product
42571-315-90Product
42571-315-05Product
42571-315-32Product
42571-315-11Product
42571-315-20Product
42571-315-91Product
42571-315-01Product
42571-316-30Product
42571-316-90Product
42571-316-32Product
42571-316-11Product
42571-316-20Product
42571-316-91Product
42571-316-01Product
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.
