Pharmakon Pharmaceuticals, Inc.

FDA Regulatory Profile

Summary

Total Recalls
116 (5 Class I)
510(k) Clearances
0
Inspections
3
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-1275-2016Class IIPromethazine 12.5mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag, Rx Only, CApril 20, 2016
D-1291-2016Class IIFentanyl Citrate 25mcg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless SyringeApril 20, 2016
D-1276-2016Class IIPromethazine 25 mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag, Rx, Only, CApril 20, 2016
D-1329-2016Class IIKetamine 2 mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless syringe, Rx OnlyApril 20, 2016
D-1339-2016Class IIRocuronium 10mg/ml 10ml fill in a 10ml BD syringe; Rx Only, Compounded by PHARMAKON Pharmaceuticals,April 20, 2016
D-1258-2016Class IIFentanyl Citrate 2 mcg/mL/Ropivacaine HCI 0.2% injection in 0.9% Sodium Chloride, 100 mL bag, Rx OnlApril 20, 2016
D-1325-2016Class IIHYDROmorphone HCI 1mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless Syringe,April 20, 2016
D-1266-2016Class IIEpinephrine (PF) 10mcg/mL in 0.9% Sodium Chloride, 5ml syringe, Rx Only, Compounded by PHARMAKON PhaApril 20, 2016
D-1320-2016Class IIFentanyl Citrate 2mcg/mL & Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 100 mL bag, Compounded by PApril 20, 2016
D-1257-2016Class IIBupivacaine 1mg/mL injection in 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON PhApril 20, 2016
D-1322-2016Class IISuccinylcholine Chloride 20 mg/mL, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON PharmaceuticalApril 20, 2016
D-1300-2016Class IIMidazolam HCI1mg/mL in 0.9% Sodium Chloride 100 mL fill in a 150 mL lntravia bag, Rx Only, CompoundeApril 20, 2016
D-1317-2016Class IIMorphine Sulfate (PF) 1mg/mL in 0.9% Sodium Chloride, 50 mL lntravia Bag IV USE ONLY, Rx Only, CompoApril 20, 2016
D-1290-2016Class IIProvocholine pre-diluted in 0.9% Sodium Chloride Set II syringes, 0.0625mg/mL,3 mL; 0.25 mg/mL 3mL;April 20, 2016
D-1327-2016Class IIPhenylephrine HCI (PF) 100mcg/mL in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PHARMApril 20, 2016
D-1340-2016Class IIVecuronium 1mg/mL in Sterile Water ,10 mL BD syringe, Rx Only, Compounded by PHARMAKON PharmaceuticaApril 20, 2016
D-1261-2016Class IICeftriaxone 1GM injection in Sterile Water, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON PharmApril 20, 2016
D-1293-2016Class IIHYDROmorphone HCI 0.2mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, Compounded by PHARMAKONApril 20, 2016
D-1269-2016Class IIFentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride 100 mL Intravia bag, Rx OnlyApril 20, 2016
D-1326-2016Class IIHYDROmorphone HCI 0.2 mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 mL Monoject Syringe, Rx Only,April 20, 2016