Class II
Terminated
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.
This recall has been terminated (originally issued October 10, 2018).
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- September 21, 2018
- Posted
- October 10, 2018
- Recall Number
- D-0001-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 313 bottles
- Firm Location
- North Wales, PA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Distribution
Distributed nationwide in the USA
Lot / Code Info
Lot #: 34034024B, Exp 02/20
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