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

FDA recall notice · announced February 28, 2024 · Micro Labs Limited

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the USA
Lot/code information: ZOAG043
Quantity: 24,768 bottles
Status: Ongoing
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.