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.
Reported: October 10, 2018 Initiated: September 21, 2018 #D-0001-2019
Product Description
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.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 313 bottles
- Distribution
- Distributed nationwide in the USA
- Location
- North Wales, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Teva Pharmaceuticals USA. Units affected: 313 bottles.
Why was this product recalled? ▼
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 10, 2018. Severity: Moderate. Recall number: D-0001-2019.
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