Status
Terminated
Drug Enforcement D-237-2013
Failed Content Uniformity Specifications: Recall is being carried out due to an out-of-specification result for content uniformity.
Classification
Class II
Report Date
April 10, 2013
Termination Date
January 15, 2014
Product Information
- Product description
- 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
- Product quantity
- 3 boxes
- Reason for recall
- Failed Content Uniformity Specifications: Recall is being carried out due to an out-of-specification result for content uniformity.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- NC
Location & Firm
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- Address
-
650 Cathill Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-237-2013
- Event ID
- 64305
- Recall initiation date
- February 7, 2013
- Center classification date
- April 1, 2013
- Code info
- Lot # 32900136A, Exp. 05/14
- More code info
- —