FDA Drug recall D-0348-2024
Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs Limited Goa-403 722, India
- FDA Drug
- Class II
- ongoing
- Published 2024-02-28
On 2024-02-28 the FDA classified a Class II recall of Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs Limited Goa-403 722, India by Micro Labs, citing CGMP Deviations: Out of specification for residual solvents.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0348-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-12 |
| Published | 2024-02-28 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Micro Labs |
| Distribution | US |
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.
Identifiers
| ndc | 42571-315-30 |
|---|---|
| ndc | 42571-315-90 |
| ndc | 42571-315-05 |
| ndc | 42571-315-32 |
| ndc | 42571-315-11 |
| ndc | 42571-315-20 |
| ndc | 42571-315-91 |
| ndc | 42571-315-01 |
| ndc | 42571-316-30 |
| ndc | 42571-316-90 |
| ndc | 42571-316-32 |
| ndc | 42571-316-11 |
| ndc | 42571-316-20 |
| ndc | 42571-316-91 |
| ndc | 42571-316-01 |
| code_info | ZOAG043 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0348-2024%22
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