FDA Drug Class II — Moderate

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

Hazard

Failed Dissolution Specifications

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Products

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
Brand
Zydus Pharmaceuticals (USA) Inc
UPC
M900412 December 2020 M904772 February 2021 M915745 October 2021

Units Affected

22,848 cartons

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