D-0146-2021 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
22,848 cartons

Product Description

Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablets (10 x 10 unit-dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-772-77

Reason for Recall

Failed Dissolution Specifications

Distribution Pattern

Nationwide

Code Information

M900412 December 2020 M904772 February 2021 M915745 October 2021