PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: December 23, 2020 Initiated: December 3, 2020 #D-0146-2021

Product Description

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

Details

Units Affected
22,848 cartons
Distribution
Nationwide
Location
Pennington, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Zydus Pharmaceuticals (USA) Inc. Units affected: 22,848 cartons.
Why was this product recalled?
Failed Dissolution Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on December 23, 2020. Severity: Moderate. Recall number: D-0146-2021.