D-0348-2024 Class II Ongoing
FDA drug recall D-0348-2024 was initiated by Micro Labs Limited on February 12, 2024 and is designated Class II. Reason for recall: CGMP Deviations: Out of specification for residual solvents. The recall status is ongoing. Affected quantity: 24,768 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 28, 2024
- Initiation Date
- February 12, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24,768 bottles
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
Reason for Recall
CGMP Deviations: Out of specification for residual solvents.
Distribution Pattern
Nationwide in the USA
Code Information
ZOAG043