Reported Feb 17, 2016 · Terminated

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

Pharmacaribe LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Pharmacaribe llc · 3513 Dileuca St · Punta Gorda, FL · 33950-7835

Is this the product you have?

  • PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic, pH 7.4
  • For Inhalation Only Rx Product UsageThe contents of these vials are used in conjunction with a nebulizer for the induction of sputum production where sputum production is indicated
Lot codes and dates
  • Lot # CIY Exp
  • Date August 2017 UPC Number030915339988 (on
  • the box of 60 vials) UPC Number10030915339985 (on the shipping case of 12 boxes)
Amount recalled
7,020 vials

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 28, 2017 · Data as of Sep 19, 6:00 PM UTC

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