FDA-Drug2020-11-11Class II

Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 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 68382-771-77

Zydus Pharmaceuticals (USA) Inc
Hazard

Failed Dissolution Specification

Sold states
Distributed Nationwide in the USA
Affected count
6,840 units
Manufactured in
73 Route 31 N, N/A, Pennington, NJ, United States
Products
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 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 68382-771-77

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0074-2021

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