D-0438-2024 Class II Terminated
FDA drug recall D-0438-2024 was initiated by NATCO Pharma Limited on March 27, 2024 and is designated Class II. Reason for recall: CGMP Deviations The recall status is terminated (terminated February 6, 2026). Affected quantity: 30 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 17, 2024
- Initiation Date
- March 27, 2024
- Termination Date
- February 6, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 bottles
Product Description
Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41
Reason for Recall
CGMP Deviations
Distribution Pattern
Nationwide in the US
Code Information
Lot#: 411988, Exp date: 05/31/2025