Drug 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.
D-0001-2019
Product summary
- Event
- Event 81068
- Status
- Terminated
- Classification
- Class II
- Quantity
- 313 bottles
- Official record key
drug-enforcement:D-0001-2019
Official wording
Reason: Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Code information: Lot #: 34034024B, Exp 02/20
Distribution pattern: Distributed nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out-of-specification