Lansoprazole Delayed-Release Capsules USP recalled over manufacturing violations

Recall date

February 1, 2024

Source

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

Official notice title

NATCO Pharma Limited recalls Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured by: Natco Pharma Limited Kothur- 509 22…

Recall number

D-0318-2024

FDA classification

Class II

Brand / firm

NATCO Pharma Limited

Sold / distributed

Nationwide in the USA

Why it was recalled

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.

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, 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