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-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-1322-2016Class IISuccinylcholine Chloride 20 mg/mL, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON PharmaceuticalApril 20, 2016
D-1287-2016Class IIKetamine 50mg/mL in 0.9% Sodium Chloride 1mL fill in 3 mL syringe, Rx Only, Compounded by PHARMAKON April 20, 2016
D-1330-2016Class IIEphedrine Sulfate 5 mg/ml in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PHARMAKON PhApril 20, 2016
D-1267-2016Class IIMidazolam (PF) 5mg/ml 25 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, NoblesvillApril 20, 2016
D-1309-2016Class IIDiltiazem HCI 250 mg in 5% Dextrose, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON PharmaceuApril 20, 2016
D-1284-2016Class IIHydromorphone HCI 0.2mg/mL in 0.9% Sodium Chloride 50 mL Cadd Cassette (grey), Rx Only, Compounded April 20, 2016
D-1337-2016Class IIFentanyl Citrate 50 mcg/mL, 5ml syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, NoblesvilApril 20, 2016
D-1319-2016Class IIFentanyl Citrate 2 mcg/mL & Bupivacaine HCL 0.125 % in 0.9% Sodium Chloride, 150 mL lntravia bag;, RApril 20, 2016
D-1331-2016Class IIRopivacaine HCI 0.2% in 0.9% Sodium Chloride, 500mL lntravia bag, Rx only, Compounded by PHARMAKON PApril 20, 2016
D-1280-2016Class IICefazolin 3GM Added to a 100 mL 0.9% Sodium Chloride Bag, Rx Only, Compounded by PHARMAKON PharmaceuApril 20, 2016
D-1292-2016Class IIHydromorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless syringApril 20, 2016
D-1268-2016Class IIAdenosine 1mg/ml (PF) in 0.9% Sodium Chloride (Total 90 mg/90 ml in 100 mL PAB Container); Rx Only, April 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-1299-2016Class IIOxytocin 20 Units added to Lactated Ringers in a 1000 mL lntravia bag, Rx Only, Compounded by PHARMAApril 20, 2016
D-1306-2016Class IIFentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride, 250 mL lntravia bag, Rx OnlApril 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-1313-2016Class IIAtropine Sulfate 0.4mg/mL 2.5 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON PharmaceutApril 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