Rugby Aller-chlor recalled over mold contamination

Recall date

August 16, 2017

Source

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

Official notice title

Pharmatech LLC recalls Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by: Rugb…

Recall number

D-0227-2018

FDA classification

Class II

Brand / firm

Pharmatech LLC

Sold / distributed

MI

Why it was recalled

Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination

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

What was recalled

Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by: Rugby Laboratories 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA --- NDC: 0536-1025-47, Manufactured by PharmaTech LLC, Davie FL