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 Nasal Saline Drops with Himalayan Salt Saline Nasal Moisturizer, 30 single-use vials per Carton,0…

Recall number

D-1633-2019

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 Nasal Saline Drops with Himalayan Salt Saline Nasal Moisturizer, 30 single-use vials per Carton,0.05 fl. oz. (1.5 mL) each 1.5 fl. oz. (45 mL) total, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428598207