FDA Drug Recalls

11,815 recalls · Class II, newest first

Class II · Moderate risk Terminated Apr 20, 2016

Oxytocin 30 Units added to 0.9% Sodium Chloride in a 500 mL lntravia bag

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0735-03 D-1295-2016

Class II · Moderate risk Terminated Apr 20, 2016

Ketamine 100mg/mL 1mL fill 3 mL syringe

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0709-78 D-1294-2016

Class II · Moderate risk Terminated Apr 20, 2016

HYDROmorphone HCI 0.2mg/ml in 0.9% Sodium Chloride

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0702-68 D-1293-2016

Class II · Moderate risk Terminated Apr 20, 2016

Hydromorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 30 mL fill in…

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0684-68 D-1292-2016

Class II · Moderate risk Terminated Apr 20, 2016

Fentanyl Citrate 25mcg/mL in 0.9% Sodium Chloride 30 mL fill in a…

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0683-68 D-1291-2016

Class II · Moderate risk Terminated Apr 20, 2016

Provocholine pre-diluted in 0.9% Sodium Chloride Set II syringes

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0674-80 D-1290-2016

Class II · Moderate risk Terminated Apr 20, 2016

Cefazolin 2GM added to 5% Dextrose 50 mL USP

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0610-41 D-1289-2016

Class II · Moderate risk Terminated Apr 20, 2016

Bupivacaine HCI 0.125% 50 mL fill in a 60 mL syringe

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0608-75 D-1288-2016

Class II · Moderate risk Terminated Apr 20, 2016

Ketamine 50mg/mL in 0.9% Sodium Chloride 1mL fill in 3 mL syringe

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0603-78 D-1287-2016

Class II · Moderate risk Terminated Apr 20, 2016

Fentanyl Citrate 25 mcg/mL in 0.9% Sodium Chloride 25 mL in 30 mL syringe

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0521-67 D-1286-2016

Class II · Moderate risk Terminated Apr 20, 2016

Fentanyl Citrate 10mcg/mL in 0.9% Sodium Chloride

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0505-41 D-1285-2016

Class II · Moderate risk Terminated Apr 20, 2016

Hydromorphone HCI 0.2mg/mL in 0.9% Sodium Chloride 50 mL Cadd Cassette

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0504-41 D-1284-2016

Class II · Moderate risk Terminated Apr 20, 2016

Morphine Sulfate 1mg/mL in 0.9% Sodium Chloride 50 mL fill in a…

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0502-41 D-1283-2016

Class II · Moderate risk Terminated Apr 20, 2016

Magnesium Sulfate 50 GM in Lactated Ringers 500 mL bag

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0407-03 D-1282-2016

Class II · Moderate risk Terminated Apr 20, 2016

Morphine Sulfate

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0322-78 D-1281-2016

Class II · Moderate risk Terminated Apr 20, 2016

Cefazolin 3GM Added to a 100 mL 0.9% Sodium Chloride Bag

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0223-48 D-1280-2016

Class II · Moderate risk Terminated Apr 20, 2016

Cefazolin 2GM added to 100 mL 0.9% Sodium Chloride bag Rx Only

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0216-48 D-1279-2016

Class II · Moderate risk Terminated Apr 20, 2016

HYDROmorphone 1mg/mL in 0.9% Sodium Chloride 1 mL fill in a 3 mL syringe

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0190-78 D-1278-2016

Class II · Moderate risk Terminated Apr 20, 2016

Phenylephrine HCI 40mg/250 mL in 0.9% Sodium Chloride 250 mL bag

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0189-02 D-1277-2016

Class II · Moderate risk Terminated Apr 20, 2016

Promethazine 25 mg added to 0.9% Sodium Chloride 50 mL fill in a…

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0187-41 D-1276-2016

Class II · Moderate risk Terminated Apr 20, 2016

Promethazine 12.5mg added to 0.9% Sodium Chloride 50 mL fill in a…

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0186-41 D-1275-2016

Class II · Moderate risk Terminated Apr 20, 2016

Methohexital

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0180-72 D-1274-2016

Class II · Moderate risk Terminated Apr 20, 2016

Promethazine 6.25 mg added to 0.9% Sodium Chloride 50 mL in 100…

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0177-41 D-1273-2016

Class II · Moderate risk Terminated Apr 20, 2016

Norepinephrine 16 mg added to 0.9% sodium Chloride

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0174-02 D-1272-2016

Class II · Moderate risk Terminated Apr 20, 2016

Potassium Chloride 40 mEq Added to 0.9% Sodium Chloride 250 mL bag

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0173-02 D-1271-2016