FDA recall D-0318-2024

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.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2024-02-01

Report date

2024-02-14

Termination date

2026-02-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rangareddy, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0318-2024