RIVASTIGMINE TRANSDERMAL SYSTEM recalled over manufacturing violations

Recall date

January 26, 2022

Source

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

Official notice title

CARDINAL HEALTHCARE recalls RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box, Rx Only, Distributed by: Alvogen, Inc.,…

Recall number

D-0196-2024

FDA classification

Class II

Brand / firm

CARDINAL HEALTHCARE

Sold / distributed

Nationwide USA

Why it was recalled

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

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

What was recalled

RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box, Rx Only, Distributed by: Alvogen, Inc., Morristown, NJ 07960. NDC 47781-304-03