FDA-Drug2020-12-23Class II

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

Zydus Pharmaceuticals (USA) Inc
Hazard

Failed Dissolution Specifications

Sold states
Nationwide
Affected count
22,848 cartons
Manufactured in
73 Route 31 N, N/A, Pennington, NJ, United States
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 Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-772-77

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0146-2021

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