FDA recall D-1006-2019

Product

Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100 tablets (10 blister cards of 10 tablets each), Rx only, Manufactured in Israel By: Teva Pharmaceutical Ind. Ltd. Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0093-3008-93

Reason for recall

Subpotent Drug.

Distribution

Nationwide in the United States.

Key facts

Status

Terminated

Initiation date

2019-03-11

Report date

2019-03-27

Termination date

2019-11-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Wales, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1006-2019