Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only. Teva Pharmaceuticals USA, INC. North Whales, PA 19454. NDC 0555-0098-96

FDA recall notice · announced October 24, 2018 · Teva Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

Failed Stability Specifications: Out-of-specification test result for water content obtained during routine stability testing.

Notes

Distribution: Product was distributed throughout the United States to various distributors who may have further distributed the product.
Lot/code information: Lot # 34033752A, EXP 1/2020
Quantity: 1,373 60-count cartons
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.