Recalls / Class II
Class IID-0348-2024
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
- Brand name
- Clobazam
- Generic name
- Clobazam
- Active ingredient
- Clobazam
- Route
- Oral
- NDCs
- 42571-315, 42571-316
- FDA application
- ANDA211711
- Affected lot / code info
- ZOAG043
Why it was recalled
CGMP Deviations: Out of specification for residual solvents.
Recalling firm
- Firm
- Micro Labs Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Plot# S - 155, & N1 Phase Iii & Phase Iv; Verna Ind Estate Road, Verna, N/A N/A, India
Distribution
- Quantity
- 24,768 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-02-12
- FDA classified
- 2024-02-22
- Posted by FDA
- 2024-02-28
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0348-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.