Recalls / Class II
Class IID-237-2013
Product
CLONAZEPAM ORALLY DISINTERGRATING Tablets, USP, 0.5 mg, 60 tablets (10 blister cards of 6 tablets each), TEVA PHARMACEUTICALS USA, Sellersville PA 18960, NDC #0555-0096-96
- Affected lot / code info
- Lot # 32900136A, Exp. 05/14
Why it was recalled
Failed Content Uniformity Specifications: Recall is being carried out due to an out-of-specification result for content uniformity.
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 650 Cathill Rd, N/A, Sellersville, Pennsylvania 18960-1512
Distribution
- Quantity
- 3 boxes
- Distribution pattern
- NC
Timeline
- Recall initiated
- 2013-02-07
- FDA classified
- 2013-04-01
- Posted by FDA
- 2013-04-10
- Terminated
- 2014-01-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-237-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.