Home / Recalls / Micro Labs Limited / D-0348-2024

D-0348-2024 Class II Ongoing

Recalled by Micro Labs Limited — Verna, N/A

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