D-0145-2021 Class II Terminated

Recalled by Zydus Pharmaceuticals (USA) Inc — Pennington, NJ

Recall Details

Product Type
Drugs
Report Date
December 23, 2020
Initiation Date
December 3, 2020
Termination Date
December 20, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15,144 cartons

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

Distribution Pattern

Nationwide

Code Information

M915744 OCT 2021 M904770 FEB 2021