FDA recall D-0001-2019

Product

Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5416-01 Yellow, round, flat-faced, beveled-edge, unscored tablet. Debossed with 13 on one side and plain on the other side.

Reason for recall

Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.

Distribution

Distributed nationwide in the USA

Key facts

Status

Terminated

Initiation date

2018-09-21

Report date

2018-10-10

Termination date

2019-05-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Wales, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0001-2019