← FDA ENFORCEMENT
D-0348-2024Class II

Micro Labs Limited

Recalling firm
Micro Labs Limited
Product type
Drug
Status
Ongoing
Report date
2024-02-28
Distribution
Nationwide in the USA
Firm state
N/A
Product quantity
24,768 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
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

Code / lot info

ZOAG043

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.