Drug recall D-0146-2021

Class II Terminated reported Dec 23, 2020

Product

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

Lots and codes

M900412 December 2020 M904772 February 2021 M915745 October 2021

Recall details

Recalling firm
Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
Quantity
22,848 cartons
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
December 3, 2020
Terminated
December 20, 2022

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