Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) b...
FDA Recall #D-0145-2021 — Class II — December 3, 2020
Product Description
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-771-77
Reason for Recall
Failed Dissolution Specifications
Recalling Firm
Zydus Pharmaceuticals (USA) Inc — Pennington, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
15,144 cartons
Distribution
Nationwide
Code Information
M915744 OCT 2021 M904770 FEB 2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated