PHARMACARIBE LLC
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
- Inspections (1)
Devices registered here (1)
- Nebulizer (Direct Patient Interface)Product code CAF (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5630
Recalls & enforcement
- Class IITerminated2015-12-29Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+)
FDA inspections (1)
- VAI2025-08-20Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “PHARMACARIBE LLC (FEI 3006500694) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006500694-pharmacaribe-llc/
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