Teva Pharmaceuticals USA recalls Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only. Teva Pharmaceuticals USA, INC. North Wha…

Recall date

September 20, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0082-2019

FDA classification

Class II

Brand / firm

Teva Pharmaceuticals USA

Sold / distributed

Product was distributed throughout the United States to various distributors who may have further distributed the product.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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