Lansoprazole Delayed-Release Capsules USP recalled over manufacturing violations

Recall date

March 27, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

NATCO Pharma Limited recalls Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bott…

Recall number

D-0438-2024

FDA classification

Class II

Brand / firm

NATCO Pharma Limited

Sold / distributed

Nationwide in the US

Why it was recalled

CGMP Deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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