FDA-Drug2024-02-28Class II

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

Micro Labs Limited
Hazard

CGMP Deviations: Out of specification for residual solvents.

Sold states
Nationwide in the USA
Affected count
24,768 bottles
Manufactured in
Plot# S - 155, & N1 Phase Iii & Phase Iv; Verna Ind Estate Road, Verna, N/A, India
Products
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

Official notice

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

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