Teva Pharmaceuticals USA recalls Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wal…

Recall date

September 21, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0001-2019

FDA classification

Class II

Brand / firm

Teva Pharmaceuticals USA

Sold / distributed

Distributed nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.