Montana Compounding Pharmacy

FDA Regulatory Profile

Summary

Total Recalls
12
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-1128-2015Class IIAlprostadil (PFE1), solution, 30 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana CompoMay 15, 2015
D-1125-2015Class IITrimix (A;PH,PA) (N), injectable, 160 UG-1.2 mg-9.6/ mg/mL, 2 mL vial, Rx only, compounded by MontanMay 15, 2015
D-1127-2015Class IITrimix (PGE1;PHENT;PAP) (N), injectable, (100/10/297) 10UG, 5 mL vial, Rx only, compounded by MontanMay 15, 2015
D-1123-2015Class IIHyaluronidase (RM ONLY), Injectable Solution, 150 U/mL, 10ML vial, Rx only, compounded by Montana CoMay 15, 2015
D-1122-2015Class IIGlutathione INHALATION (PF), NASAL solution, 100 mg/mL, 3 mL vial, Rx only, dispensed by Montana ComMay 15, 2015
D-1120-2015Class IIBimix (PHENT;PAP) (N), solution, (10/300) 1 - 30 mg/mL, injectable, 5ml vial, Rx only, compounded byMay 15, 2015
D-1124-2015Class IITrimix (A;PH,PA) (N), injectable, 80 UG-0.6 mg-4.8 mg/mL, 1 mL vial, Rx only, compounded by Montana May 15, 2015
D-1119-2015Class IIAvastin, solution, 1.25 mg/0.05mL, Injectable, Syringe, Rx only, compounded by Montana Compounding PMay 15, 2015
D-1118-2015Class IIAlprostadil (PFE1), solution, 20 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana CompoMay 15, 2015
D-1121-2015Class IIGlutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only, dispensed by Montana CompoundinMay 15, 2015
D-1117-2015Class IIAlprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana CompoMay 15, 2015
D-1126-2015Class IITrimix (PGE1;PHENT;PAP) (N), injectable, (100/10/240) 10UG, 5 mL vial, Rx only, compounded by MontanMay 15, 2015