Pharmacaribe llc

FDA Regulatory Profile

Pharmacaribe llc appears in FDA public data with 1 recall, 4 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0795-2016, Class II) was initiated on December 29, 2015. Its most recent 510(k) clearance was granted on March 13, 2013.

Summary

Total Recalls
1
510(k) Clearances
4
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0795-2016Class IIPharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pDecember 29, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K130091PULMOSALMarch 13, 2013
K101532NESSI OTC SPACERSeptember 1, 2010
K101424PHARMACARIBE INHALED SALINE SOLUTIONSAugust 17, 2010
K091862NESSI SPACERNovember 20, 2009