Pharmacaribe llc recalls PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic, pH 7.4 Fo…

Recall date

December 29, 2015

Source

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

Recall number

Z-0795-2016

FDA classification

Class II

Brand / firm

Pharmacaribe llc

Sold / distributed

US Nationwide Distribution in the states of FL, LA, TX and VA

Why it was recalled

Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+)

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

What was recalled

PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic, pH 7.4 For Inhalation Only Rx Product Usage: The contents of these vials are used in conjunction with a nebulizer for the induction of sputum production where sputum production is indicated.