Amitriptyline HCL Tablets recalled over labeling errors

Recall date

April 20, 2017

Source

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

Official notice title

C. O. Truxton recalls Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactured for: Qualitest Pharmaceuticals Huntsvill…

Recall number

D-1115-2017

FDA classification

Class II

Brand / firm

C. O. Truxton

Sold / distributed

Nationwide

Why it was recalled

Labeling: Label Mixup; potentially mislabeled

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

What was recalled

Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811, Distributed by: Truxton, Inc. Bellmawr, NJ 08031, NDC: 0463-6352-10