Drug recall
PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic…
FDA recall event 73053 · Class II · Pharmacaribe llc
Key facts
| Event ID | 73053 |
|---|---|
| Recall numbers | Z-0795-2016 |
| Recalling firm | Pharmacaribe llc |
| Product type | Devices |
| 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+) |
| Initiation date | Dec 29, 2015 |
| Report date | Feb 17, 2016 |
| Termination date | Mar 28, 2017 |
| City | Punta Gorda |
| State | FL |
| Country | United States |
| FEI number | 3006500694 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: