Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-d...
FDA Recall #D-0074-2021 — Class II — October 27, 2020
Product Description
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-dose), 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 Specification
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
6,840 units
Distribution
Distributed Nationwide in the USA
Code Information
Lot # M005681, EXP 3/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated