Drug 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
D-237-2013
Product summary
- Event
- Event 64305
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 boxes
- Official record key
drug-enforcement:D-237-2013
Official wording
Reason: Failed Content Uniformity Specifications: Recall is being carried out due to an out-of-specification result for content uniformity.
Code information: Lot # 32900136A, Exp. 05/14
Distribution pattern: NC
Derived failure modes
-
Potency or specification failure
out-of-specification