Pharmakon Pharmaceuticals
Pharmakon Pharmaceuticals appears in FDA public data with 116 recalls — including 5 Class I (most serious) —, 0 510(k) clearances, 3 FDA inspections, and 1 compliance action on record. Its most recent recall (D-1275-2016, Class II) was initiated on April 20, 2016.
Summary
- Total Recalls
- 116 (5 Class I)
- 510(k) Clearances
- 0
- Inspections
- 3
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-1275-2016 | Class II | Promethazine 12.5mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag, Rx Only, C | April 20, 2016 |
| D-1266-2016 | Class II | Epinephrine (PF) 10mcg/mL in 0.9% Sodium Chloride, 5ml syringe, Rx Only, Compounded by PHARMAKON Pha | April 20, 2016 |
| D-1339-2016 | Class II | Rocuronium 10mg/ml 10ml fill in a 10ml BD syringe; Rx Only, Compounded by PHARMAKON Pharmaceuticals, | April 20, 2016 |
| D-1287-2016 | Class II | Ketamine 50mg/mL in 0.9% Sodium Chloride 1mL fill in 3 mL syringe, Rx Only, Compounded by PHARMAKON | April 20, 2016 |
| D-1296-2016 | Class II | Oxytocin 20 Units added to 0.9% Sodium Chloride in a 1000mL lntravia bag, Compounded by PHARMAKON P | April 20, 2016 |
| D-1312-2016 | Class II | Hydromorphone HCI 1 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag IV USE ONLY, Rx Only, Compoun | April 20, 2016 |
| D-1340-2016 | Class II | Vecuronium 1mg/mL in Sterile Water ,10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceutica | April 20, 2016 |
| D-1293-2016 | Class II | HYDROmorphone HCI 0.2mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, Compounded by PHARMAKON | April 20, 2016 |
| D-1308-2016 | Class II | Fentanyl Citrate 2.5 mcg/mL & Bupivacaine 0.075% in 0.9% Sodium Chloride, 60 mL BD syringe, Rx Only, | April 20, 2016 |
| D-1343-2016 | Class II | Bupivacaine HCI 0.25% in 0.9% Sodium Chloride, 500 mL Intravia bag, Rx Only, Compounded by PHARMAKO | April 20, 2016 |
| D-1344-2016 | Class II | Sufentanil Citrate 0.4mcg/mL & Bupivacaine 0.1% in 0.9% Sodium Chloride 250 mL Intravia Bag, Rx Onl | April 20, 2016 |
| D-1335-2016 | Class II | Cefazolin 1GM in Sterile Water, 10 ml BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, | April 20, 2016 |
| D-1282-2016 | Class II | Magnesium Sulfate 50 GM in Lactated Ringers 500 mL bag; Rx Only, Compounded by PHARMAKON Pharmaceuti | April 20, 2016 |
| D-1311-2016 | Class II | Norepinephrine Bitartrate 4 mg (16mcg/mL) added to 5% Dextrose, 250 mL bag;, Rx Only, Compounded by | April 20, 2016 |
| D-1321-2016 | Class II | Bupivacaine HCI 0.125% in 0.9% Sodium Chloride, 250 mL lntravia bag, Rx Only,Compounded by PHARMAK | April 20, 2016 |
| D-1301-2016 | Class II | Epinephrine HCI 5 mcg/mL in 0.9% Sodium Chloride, 10mL syringe, Rx Only, Compounded by PHARMAKON Pha | April 20, 2016 |
| D-1297-2016 | Class II | Oxytocin 10 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAK | April 20, 2016 |
| D-1289-2016 | Class II | Cefazolin 2GM added to 5% Dextrose 50 mL USP, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Nobl | April 20, 2016 |
| D-1333-2016 | Class II | Rocuronium 10 mg/mL, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN | April 20, 2016 |
| D-1326-2016 | Class II | HYDROmorphone HCI 0.2 mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 mL Monoject Syringe, Rx Only, | April 20, 2016 |