Clobazam Tablets 10mg recalled over manufacturing violations

Recall date

February 12, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Micro Labs Limited recalls Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs Limited Goa-403 722, India. Manufactured…

Recall number

D-0348-2024

FDA classification

Class II

Brand / firm

Micro Labs Limited

Sold / distributed

Nationwide in the USA

Why it was recalled

CGMP Deviations: Out of specification for residual solvents.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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