FDA recall D-0146-2021

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2020-12-03

Report date

2020-12-23

Termination date

2022-12-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pennington, NJ, United States

Primary source

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