Leader Nasal Decongestant PE recalled over manufacturing violations

Recall date

January 26, 2022

Source

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

Official notice title

CARDINAL HEALTHCARE recalls Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health, Dublin,…

Recall number

D-0186-2024

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

Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health, Dublin, Ohio 43017. NDC: 70000-0126-1