D-0082-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 24, 2018
- Initiation Date
- September 20, 2018
- Termination Date
- November 7, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,373 60-count cartons
Product Description
Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only. Teva Pharmaceuticals USA, INC. North Whales, PA 19454. NDC 0555-0098-96
Reason for Recall
Failed Stability Specifications: Out-of-specification test result for water content obtained during routine stability testing.
Distribution Pattern
Product was distributed throughout the United States to various distributors who may have further distributed the product.
Code Information
Lot # 34033752A, EXP 1/2020