FDAClass IIFebruary 17, 2016

PharmaCaribe PulmoSal 7% Sodium chloride recall

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

Why was PharmaCaribe PulmoSal 7% Sodium chloride recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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)

Product
PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic, pH 7.4 For Inhalation Only Rx Product…
Recalling firm
Pharmacaribe llc
Quantity
7,020 vials
Distribution
US Nationwide Distribution in the states of FL, LA, TX and VA
Recall date
February 17, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls