Drug product
Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only. Teva Pharmaceuticals USA, INC. North Whales, PA 19454. NDC 0555-0098-96
D-0082-2019
Product summary
- Event
- Event 81069
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,373 60-count cartons
- Official record key
drug-enforcement:D-0082-2019
Official wording
Reason: Failed Stability Specifications: Out-of-specification test result for water content obtained during routine stability testing.
Code information: Lot # 34033752A, EXP 1/2020
Distribution pattern: Product was distributed throughout the United States to various distributors who may have further distributed the product.
Derived failure modes
-
Potency or specification failure
Out-of-specification