Purdue Pharma L.P.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
8
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0810-2016Class IIIIntermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons, Rx Only. Dist by PurdMarch 31, 2016
D-1278-2015Class IIIIntermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches per carton,July 13, 2015