American Health Packaging recalls Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister cards), Rx Only, Packaged and Distributed by:…

Recall date

December 4, 2019

Source

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

Recall number

D-0854-2020

FDA classification

Class II

Brand / firm

American Health Packaging

Sold / distributed

Nationwide within the United States

Why it was recalled

Failed Dissolution Specifications: Low out of specification results obtained during 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

Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister cards), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-266-21; NDC Unit Dose: 60687-266-11