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.

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

PharmaCaribe, together with its Contract Manufacturing firm Asept Pak, Inc., have initiated or completed the following actions to issued an Urgent Notice: Field Notification to Medical Device letter dated January t7, 2016. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to: Determine what is on hand and what has been distributed. Using the Return Notice provided, report this information as per the instructions on the notice. Please record units as either cases or as cartons (if the cases have been opened and are partial). This document is to be returned via mail or email as per the guidance provided. This will inform the Manufacturer of your inventory status and of your intentions regarding product replacement. Cases of this product may be returned for new cases of the same product (different lot) that have the correct embossing on the vials. Instructions for return are provided in the Field Notification Package Cover Letter. Alternatively, customers may choose to be issued a full refund for all returned product. For cases which have already been distributed to the retail/clinician level and/or are in use by patients, it is acceptable to continue to use the product, with the understanding (and proper communication to all parties) that the tabs on the vials are incorrectly labeled. Contact information: Lisa Early, QA Manager Asept Pak, Inc. Phone: 518-651-2026 Fax: 518-651-2046 E-mail: [email protected]