FDA Drug Recalls

14,801 recalls, newest first

Class II · Moderate risk Terminated Apr 20, 2016

Ropivacaine HCI 0.2% in 0.9% Sodium Chloride

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0942-03 D-1331-2016

Class II · Moderate risk Terminated Apr 20, 2016

Ephedrine Sulfate 5 mg/ml in 0.9% Sodium Chloride

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0939-70 D-1330-2016

Class II · Moderate risk Terminated Apr 20, 2016

Ketamine 2 mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL…

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0938-68 D-1329-2016

Class II · Moderate risk Terminated Apr 20, 2016

Morphine Sulfate 5mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD Syringe

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0935-67 D-1328-2016

Class II · Moderate risk Terminated Apr 20, 2016

Phenylephrine HCI

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0934-70 D-1327-2016

Class II · Moderate risk Terminated Apr 20, 2016

HYDROmorphone HCI 0.2 mg/mL in 0.9% Sodium Chloride 50 mL fill in…

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0933-75 D-1326-2016

Class II · Moderate risk Terminated Apr 20, 2016

HYDROmorphone HCI 1mg/mL in 0.9% Sodium Chloride 30 mL fill in a…

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0932-68 D-1325-2016

Class II · Moderate risk Terminated Apr 20, 2016

Phenylephrine HCI100mcg/mL in 0.9% sodium Chloride 10ml fill in a…

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0927-72 D-1324-2016

Class II · Moderate risk Terminated Apr 20, 2016

Ketamine 20 mg/mL in 0.9% Sodium Chloride

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0925-41 D-1323-2016

Class II · Moderate risk Terminated Apr 20, 2016

Succinylcholine Chloride 20 mg/mL

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0920-72 D-1322-2016

Class II · Moderate risk Terminated Apr 20, 2016

Bupivacaine HCI 0.125% in 0.9% Sodium Chloride

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0909-02 D-1321-2016

Class II · Moderate risk Terminated Apr 20, 2016

Fentanyl Citrate 2mcg/mL & Ropivacaine HCI 0.2% in 0.9% Sodium Chloride

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 5183-0906-48 D-1320-2016

Class II · Moderate risk Terminated Apr 20, 2016

Fentanyl Citrate 2 mcg/mL & Bupivacaine HCL 0.125 % in 0.9% Sodium Chloride

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0905-48 D-1319-2016

Class II · Moderate risk Terminated Apr 20, 2016

Vancomycin HCL 1.25 GM added to 5% Dextrose in a 250 mL lntravia bag

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0885-02 D-1318-2016

Class II · Moderate risk Terminated Apr 20, 2016

Morphine Sulfate

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0877-41 D-1317-2016

Class II · Moderate risk Terminated Apr 20, 2016

Morphine Sulfate 1mg/mL

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0876-41 D-1316-2016

Class II · Moderate risk Terminated Apr 20, 2016

Morphine Sulfate 1 mg/mL in 5% Dextrose

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0875-02 D-1315-2016

Class II · Moderate risk Terminated Apr 20, 2016

Fentanyl Citrate 10 mcg/mL

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0869-48 D-1314-2016

Class II · Moderate risk Terminated Apr 20, 2016

Atropine Sulfate 0.4mg/mL 2.5 mL fill in a 3 mL syringe

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0867-71 D-1313-2016

Class II · Moderate risk Terminated Apr 20, 2016

Hydromorphone HCI 1 mg/mL in 0.9% Sodium Chloride

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0865-41 D-1312-2016

Class II · Moderate risk Terminated Apr 20, 2016

Norepinephrine Bitartrate 4 mg

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0855-02 D-1311-2016

Class II · Moderate risk Terminated Apr 20, 2016

Fentanyl Citrate 5 mcg/mL & Bupivacaine 0.06% in 0.9% Sodium Chloride

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0827-77 D-1310-2016

Class II · Moderate risk Terminated Apr 20, 2016

Diltiazem HCI 250 mg in 5% Dextrose

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0853-02 D-1309-2016

Class II · Moderate risk Terminated Apr 20, 2016

Fentanyl Citrate 2.5 mcg/mL & Bupivacaine 0.075% in 0.9% Sodium Chloride

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0826-77 D-1308-2016

Class II · Moderate risk Terminated Apr 20, 2016

Morphine Sulfate

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0823-75 D-1307-2016