FDA recall D-0438-2024

Product

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

Nationwide in the US

Key facts

Status

Terminated

Initiation date

2024-03-27

Report date

2024-04-17

Termination date

2026-02-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rangareddy, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0438-2024