Drug Enforcement D-0348-2024

CGMP Deviations: Out of specification for residual solvents.

Status

Ongoing

Classification

Class II

Report Date

February 28, 2024

Termination Date

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Product Information

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
Product quantity
24,768 bottles
Reason for recall
CGMP Deviations: Out of specification for residual solvents.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Micro Labs Limited
Address
Plot# S - 155, & N1 Phase Iii & Phase Iv; Verna Ind Estate Road

India
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0348-2024
Event ID
93975
Recall initiation date
February 12, 2024
Center classification date
February 22, 2024
Code info
ZOAG043
More code info
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