Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablets (10 x 10 unit-dose...
FDA Recall #D-0146-2021 — Class II — December 3, 2020
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
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
22,848 cartons
Distribution
Nationwide
Code Information
M900412 December 2020 M904772 February 2021 M915745 October 2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated