Teva Pharmaceuticals USA recalls Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wale
Recalled October 10, 2018 · FDA recall D-0001-2019 · Teva Pharmaceuticals USA
Hazard
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing. · FDA Class II
Units
313 bottles
Sold at
Distributed nationwide in the USA
Description
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
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.
Manufacturer(s)
Teva Pharmaceuticals USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →