D-0318-2024 Class II Terminated
FDA drug recall D-0318-2024 was initiated by NATCO Pharma Limited on February 1, 2024 and is designated Class II. Reason for recall: CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on on… The recall status is terminated (terminated February 6, 2026). Affected quantity: 4260 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 14, 2024
- Initiation Date
- February 1, 2024
- Termination Date
- February 6, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4260 bottles
Product Description
Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count 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: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.
Distribution Pattern
Nationwide in the USA
Code Information
Lot # 411987 Exp: 05/2025