FDA-Device2016-02-17Class II
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.
Pharmacaribe llc
Hazard
Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+)
Sold states
US Nationwide Distribution in the states of FL, LA, TX and VA
Affected count
7,020 vials
Manufactured in
3513 Dileuca St, N/A, Punta Gorda, FL, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0795-2016Don't want to check this manually?
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