Drug 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
D-0348-2024
Product summary
- Event
- Event 93975
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 24,768 bottles
- Official record key
drug-enforcement:D-0348-2024
Official wording
Reason: CGMP Deviations: Out of specification for residual solvents.
Code information: ZOAG043
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Potency or specification failure
Out of specification