DrKids Children's Allergy Relief Diphenhydramine HCl 12 recalled over manufacturing violations

Recall date

July 15, 2019

Source

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

Official notice title

Unipharma, Llc. recalls DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, Mixed berry Flavor, 20 Pre-measured Si…

Recall number

D-1632-2019

FDA classification

Class II

Brand / firm

Unipharma, Llc.

Sold / distributed

Nationwide in the US.

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 Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, Mixed berry Flavor, 20 Pre-measured Single-Use vials per Carton, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, UPC 370302255010