FDA-Drug2018-10-10Class II
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.
Teva Pharmaceuticals USA
Hazard
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Sold states
Distributed nationwide in the USA
Affected count
313 bottles
Manufactured in
1090 Horsham Rd, North Wales, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0001-2019Don't want to check this manually?
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