PlainRecalls
FDA Drug Moderate Class II Terminated

Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 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 68382-772-77

Reported: November 11, 2020 Initiated: October 27, 2020 #D-0075-2021

Product Description

Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 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 68382-772-77

Reason for Recall

Failed Dissolution Specification

Details

Units Affected
7,908 units
Distribution
Distributed Nationwide in the USA
Location
Pennington, NJ

Frequently Asked Questions

What product was recalled?
Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 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 68382-772-77. Recalled by Zydus Pharmaceuticals (USA) Inc. Units affected: 7,908 units.
Why was this product recalled?
Failed Dissolution Specification
Which agency issued this recall?
This recall was issued by the FDA Drug on November 11, 2020. Severity: Moderate. Recall number: D-0075-2021.