PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, No...
FDA Recall #Z-0795-2016 — Class II — December 29, 2015
Product Description
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.
Reason for Recall
Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+)
Recalling Firm
Pharmacaribe llc — Punta Gorda, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
7,020 vials
Distribution
US Nationwide Distribution in the states of FL, LA, TX and VA
Code Information
Lot # CIY Exp.Date August 2017 UPC Number: 030915339988 (on the box of 60 vials) UPC Number: 10030915339985 (on the shipping case of 12 boxes)
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated