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
Reported: February 28, 2024 Initiated: February 12, 2024 #D-0348-2024
Product Description
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.
Details
- Recalling Firm
- Micro Labs Limited
- Units Affected
- 24,768 bottles
- Distribution
- Nationwide in the USA
- Location
- Verna, N/A
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Micro Labs Limited. Units affected: 24,768 bottles.
Why was this product recalled? ▼
CGMP Deviations: Out of specification for residual solvents.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 28, 2024. Severity: Moderate. Recall number: D-0348-2024.
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