Clobazam Tablets 10mg recall
FDA recall D-0348-2024 · initiated Feb 12, 2024
Micro Labs Limited recalled Clobazam Tablets 10mg in Feb 2024 — an FDA Class II recall (D-0348-2024) because CGMP Deviations: Out of specification for residual solvents.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: Out of specification for residual solvents.
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 24,768 bottles
Details
- 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
- Recalling company
- Micro Labs
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Feb 12, 2024
- FDA report date
- Feb 28, 2024
Frequently asked
- Was Clobazam Tablets 10mg recalled?
- Micro Labs Limited recalled Clobazam Tablets 10mg in Feb 2024 — an FDA Class II recall (D-0348-2024) because CGMP Deviations: Out of specification for residual solvents. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Clobazam Tablets 10mg recalled?
- Per the FDA enforcement record, the reason for recall D-0348-2024 was: CGMP Deviations: Out of specification for residual solvents.
- Is a recalled Clobazam Tablets 10mg dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Clobazam Tablets 10mg are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — ZOAG043. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0348-2024.