Recalls / Class II
Class IID-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.
- Brand name
- Clozapine
- Generic name
- Clozapine
- Active ingredient
- Clozapine
- Route
- Oral
- NDCs
- 0093-5376, 0093-5416, 0093-5417, 0093-5419, 0093-5377
- FDA application
- ANDA090308
- Affected lot / code info
- Lot #: 34034024B, Exp 02/20
Why it was recalled
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 313 bottles
- Distribution pattern
- Distributed nationwide in the USA
Timeline
- Recall initiated
- 2018-09-21
- FDA classified
- 2018-10-01
- Posted by FDA
- 2018-10-10
- Terminated
- 2019-05-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0001-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.