Micro Labs Limited: Drug Recall

Recall #D-0348-2024 · 02/12/2024

Class II: Risk

Recall Details

Recall Number
D-0348-2024
Classification
Class II
Product Type
Drug
Recalling Firm
Micro Labs Limited
Status
Ongoing
Date Initiated
02/12/2024
Location
Verna, N/A, India
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
24,768 bottles

Reason for Recall

CGMP Deviations: Out of specification for residual solvents.

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

Distribution Pattern

Nationwide in the USA

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.