FDA recall D-0348-2024

Product

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

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2024-02-12

Report date

2024-02-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Verna, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0348-2024