Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs Limited Goa-403 722...
FDA Recall #D-0348-2024 — Class II — February 12, 2024
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.
Recalling Firm
Micro Labs Limited — Verna, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
24,768 bottles
Distribution
Nationwide in the USA
Code Information
ZOAG043
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated