Drug recall D-0318-2024

Class II Terminated reported Feb 14, 2024

Product

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.

Lots and codes

Lot # 411987 Exp: 05/2025

Recall details

Recalling firm
NATCO Pharma Limited, Rangareddy
Quantity
4260 bottles
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
February 1, 2024
Terminated
February 6, 2026