Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

PharmaCaribe PulmoSal 7% Sodium chloride Recalled by Pharmacaribe llc Due to Vials were labeled as USP 7% Hypertonic saline...

Date: December 29, 2015
Company: Pharmacaribe llc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Pharmacaribe llc directly.

Affected Products

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.

Quantity: 7,020 vials

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Pharmacaribe llc

Pharmacaribe llc has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report