DrKids Children's Natural Cough Syrup English Ivy Leaf recalled over manufacturing violations

Recall date

September 23, 2019

Source

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

Official notice title

Unipharma, Llc. recalls DrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL) E…

Recall number

D-0132-2020

FDA classification

Class II

Brand / firm

Unipharma, Llc.

Sold / distributed

U.S.A. Nationwide

Why it was recalled

CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

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

What was recalled

DrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL) Each 3.4 fl. oz. (100 mL), Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 33321 UPC 370302489026