FDA Recall D-0348-2024
Micro Labs Limited · Verna, N/A
Class II Ongoing 822 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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 for recall
CGMP Deviations: Out of specification for residual solvents.
Recall record
- Recall number
D-0348-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2024-02-12
- Classified by FDA Center
- 2024-02-22
- FDA published
- 2024-02-28
- Recalling firm
- Micro Labs Limited
- Firm location
- Verna, N/A, India
Drug identification
- Brand name(s)
- CLOBAZAM
- Generic name(s)
- CLOBAZAM
- Manufacturer(s)
- Micro Labs Limited
- NDC(s)
42571-315, 42571-316- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.