Clozapine Orally Disintegrating Tablets recall
Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5416-01…
Why was Clozapine Orally Disintegrating Tablets recalled?
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 34034024B, Exp 02/20
- 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…
- Recalling firm
- Teva Pharmaceuticals USA
- Quantity
- 313 bottles
- Distribution
- Distributed nationwide in the USA
- Recall date
- October 10, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)