Unipharma product recalled over manufacturing violations

Recall date

July 15, 2019

Source

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

Official notice title

Unipharma, Llc. recalls CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution, Antihistamine, M…

Recall number

D-1631-2019

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

CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution, Antihistamine, Mixed Berry Flavor, 20 Single-Use Vials per Carton, 0.17 fl. oz. (5 mL) Each, 3.4 fl. oz. (100 mL) Total Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 69842-261-01 UPC 050428597156