Recall: D-0001-2019

Class II - Potentially Harmful

Class IIClassification

2018-09-21Initiated

TerminatedStatus

Teva Pharmaceuticals USAFirm

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

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

Distribution

Distributed nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.