Why it was recalled
CGMP Deviations: Out of specification for residual solvents.
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
Lot numbers, UPCs & expiration codes
ZOAG043
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0348-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 12, 2024
- FDA report date
- Feb 28, 2024
- Quantity
- 24,768 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Micro Labs Limited
Original FDA data
Every field from FDA enforcement report D-0348-2024, exactly as published.
Show all FDA fields
- City
- Verna
- Status
- Ongoing
- Country
- India
- Event ID
- 93975
- Address
- Plot# S - 155
- Address (line 2)
- & N1 Phase Iii & Phase Iv; Verna Ind Estate Road
- Code information
- ZOAG043
- Report date
- Feb 28, 2024
- Product type
- Drugs
- Recall number
- D-0348-2024
- Classification
- Class II
- Recalling firm
- Micro Labs Limited
- Product quantity
- 24,768 bottles
- Reason for recall
- CGMP Deviations: Out of specification for residual solvents.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Feb 12, 2024
- Initial firm notification
- Letter
- Center classification date
- Feb 22, 2024