Recall: D-0348-2024

Class II - Potentially Harmful

Class IIClassification

2024-02-12Initiated

OngoingStatus

Micro Labs LimitedFirm

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

CGMP Deviations: Out of specification for residual solvents.

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.