Class II — Pharmacaribe llc
| Recalling firm | Pharmacaribe LLC |
|---|---|
| Registered facility | PHARMACARIBE LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+) |
| Product | 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. |
| Quantity | 7,020 vials |
| Distribution | US Nationwide Distribution in the states of FL, LA, TX and VA |
| Initiated | 2015-12-29 |
| Classified | 2016-02-10 |
| Terminated | 2017-03-28 |
| Recall number | Z-0795-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Pharmacaribe llc (Z-0795-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73053/
Alerts for Pharmacaribe LLC
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.