Drug 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.
Lots and codes
Lot #: 34034024B, Exp 02/20
Recall details
- Recalling firm
- Teva Pharmaceuticals USA, North Wales, PA
- Quantity
- 313 bottles
- Distribution
- Distributed nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 21, 2018
- Terminated
- May 1, 2019
Related products
- Clozapine – drug information
- NDC 0093-5377 Clozapine · Clozapine 200 mg/1 · Teva Pharmaceuticals USA, Inc.
- NDC 0093-5417 Clozapine · Clozapine 25 mg/1 · Teva Pharmaceuticals USA, Inc.
- NDC 0093-5376 Clozapine · Clozapine 150 mg/1 · Teva Pharmaceuticals USA, Inc.
- NDC 0093-5416 Clozapine · Clozapine 12.5 mg/1 · Teva Pharmaceuticals USA, Inc.
- NDC 0093-5419 Clozapine · Clozapine 100 mg/1 · Teva Pharmaceuticals USA, Inc.