D-0074-2021 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
November 11, 2020
Initiation Date
October 27, 2020
Termination Date
December 20, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6,840 units

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

Distribution Pattern

Distributed Nationwide in the USA

Code Information

Lot # M005681, EXP 3/2022