Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister cards), Rx Only, Package...
FDA Recall #D-0854-2020 — Class II — December 4, 2019
Product Description
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
Reason for Recall
Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
Recalling Firm
American Health Packaging — Columbus, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
973 cartons
Distribution
Nationwide within the United States
Code Information
Lot #:180276A, Exp date 02/29/2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated