DrKids Himasal Natural Nasal Saline Solution 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 Himasal Natural Nasal Saline Solution, packaged in Pre-measured Singe-Use Vials a) 0.5 mL Each (20 count) UPC 37…

Recall number

D-0133-2020

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 Himasal Natural Nasal Saline Solution, packaged in Pre-measured Singe-Use Vials a) 0.5 mL Each (20 count) UPC 37030244608; b) 1.5 mL Each (20 count) UPC 370302446098, Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 33321