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FDA Drug Recalls

18043 recall notices on file. Class I recalls involve a reasonable probability of serious adverse health consequences or death.

ProductFirmClassificationStatusReport date
Phenylephrine HCI 40mg/250 mL in 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0189-02 Pharmakon Pharmaceuticals, Inc. Class II Terminated 20160720
Promethazine 25 mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag, Rx, Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0187-41 Pharmakon Pharmaceuticals, Inc. Class II Terminated 20160720
Promethazine 12.5mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0186-41 Pharmakon Pharmaceuticals, Inc. Class II Terminated 20160720
Methohexital (Brevital Sodium) 10 mg/mL,10 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0180-72 Pharmakon Pharmaceuticals, Inc. Class II Terminated 20160720
Promethazine 6.25 mg added to 0.9% Sodium Chloride 50 mL in 100 mL B/Braun PAB bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0177-41 Pharmakon Pharmaceuticals, Inc. Class II Terminated 20160720
Norepinephrine 16 mg added to 0.9% sodium Chloride, 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0174-02 Pharmakon Pharmaceuticals, Inc. Class II Terminated 20160720
Potassium Chloride 40 mEq Added to 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0173-02 Pharmakon Pharmaceuticals, Inc. Class II Terminated 20160720
Fentanyl Citrate 2mcg/mL & Bupivacaine 0.125% in 0.9% Sodium Chloride 150 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0171-01 Pharmakon Pharmaceuticals, Inc. Class II Terminated 20160720
Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride 100 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0148-48 Pharmakon Pharmaceuticals, Inc. Class II Terminated 20160720
Adenosine 1mg/ml (PF) in 0.9% Sodium Chloride (Total 90 mg/90 ml in 100 mL PAB Container); Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0146-47 Pharmakon Pharmaceuticals, Inc. Class II Terminated 20160720
Midazolam (PF) 5mg/ml 25 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0138-67 Pharmakon Pharmaceuticals, Inc. Class II Terminated 20160720
Epinephrine (PF) 10mcg/mL in 0.9% Sodium Chloride, 5ml syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0135-70 Pharmakon Pharmaceuticals, Inc. Class II Terminated 20160720
Epinephrine 100mcg/mL injection in 0.9% Sodium Chloride 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0120-72 Pharmakon Pharmaceuticals, Inc. Class II Terminated 20160720
Propofol1% 10mg/mL injection, 20 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0119-73 Pharmakon Pharmaceuticals, Inc. Class II Terminated 20160720
Fentanyl Citrate injection, 50 mcg/mL, 50 mL lntravia IV Bag Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0118-41 Pharmakon Pharmaceuticals, Inc. Class II Terminated 20160720
Hydromorphone HCl 1mg/ml injection in 0.9% Sodium Chloride, 100 mL Cadd Cassette (grey), Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0114-48 Pharmakon Pharmaceuticals, Inc. Class II Terminated 20160720
Ceftriaxone 1GM injection in Sterile Water, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0106-72 Pharmakon Pharmaceuticals, Inc. Class II Terminated 20160720
Succinylcholine Chloride 20 mg/mL injection , 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0104-70 Pharmakon Pharmaceuticals, Inc. Class II Terminated 20160720
Fentanyl Citrate 50 mcg/ml injection, 2mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0100-69 Pharmakon Pharmaceuticals, Inc. Class II Terminated 20160720
Fentanyl Citrate 2 mcg/mL/Ropivacaine HCI 0.2% injection in 0.9% Sodium Chloride, 100 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0029-01 Pharmakon Pharmaceuticals, Inc. Class II Terminated 20160720
Bupivacaine 1mg/mL injection in 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0019-02 Pharmakon Pharmaceuticals, Inc. Class II Terminated 20160720
Phenylephrine 40 mcg/mL injection in 0.9% Sodium Chloride 10 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0011-72 Pharmakon Pharmaceuticals, Inc. Class II Terminated 20160720
DULOXETINE Delayed-Release Capsules, USP, 60 mg, 1000 count bottles, Rx only, Manufactured by: Laboratorios del Dr. Esteve, SA, Martorelles, Barcelona --- NDC 60429-166-10 Golden State Medical Supply Inc. Class III Terminated 20160720
HCL 2MG/ML (PF), 5ML Vials, MEDAUS PHARMACY Medaus, Inc. Class II Terminated 20160720
ZINC SO4 1MG/ML (PF), 2ML Vials, MEDAUS PHARMACY Medaus, Inc. Class II Terminated 20160720
ARGININE 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY Medaus, Inc. Class II Terminated 20160720
ZINC SO4 10MG/ML (PF), Vials 2ML, MEDAUS PHARMACY Medaus, Inc. Class II Terminated 20160720
ZINC CHLORIDE 10MG/ML IN NACL 0.29% (PF), 2ML Vials, MEDAUS PHARMACY Medaus, Inc. Class II Terminated 20160720
TRYPTOPHAN 10MG/ML (PF), In a) 10ML Vials and b) 50ML Vials, MEDAUS PHARMACY Medaus, Inc. Class II Terminated 20160720
TMG 100 MG/ML (PF), 10ML Vials, MEDAUS PHARMACY Medaus, Inc. Class II Terminated 20160720
THIAMINE 100 MG/ML W/PRES (BENZALKONIUM 0.01%), 5ML Vials, MEDAUS PHARMACY Medaus, Inc. Class II Terminated 20160720
THIAMINE 100 MG/ML, 2ML Vials, MEDAUS PHARMACY Medaus, Inc. Class II Terminated 20160720
TESTOSTERONE CYP 50 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, d) 4ML Vials, and e) 5ML Vials, MEDAUS PHARMACY Medaus, Inc. Class II Terminated 20160720
TESTOSTERONE CYP 25 MG/ML W/PRES (BENZYL ETOH 2%), 5ML Vials, MEDAUS PHARMACY Medaus, Inc. Class II Terminated 20160720
TESTOSTERONE CYP 20 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials and b) 3ML Vials, MEDAUS PHARMACY Medaus, Inc. Class II Terminated 20160720
TESTOSTERONE CYP 200 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, d) 4ML, and e) 5ML Vials, MEDAUS PHARMACY Medaus, Inc. Class II Terminated 20160720
TESTOSTERONE CYP 100 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, and d) 5 ML Vials, MEDAUS PHARMACY Medaus, Inc. Class II Terminated 20160720
TAURINE 50 MG/ML W/PRES. (BENZALKONIUM CHL 0.01%), 10ML Vials, MEDAUS PHARMACY Medaus, Inc. Class II Terminated 20160720
TAURINE 50 MG/ML (PF), In a) 1ML Vials, b) 10ML Vials, and c) 20ML Vials, MEDAUS PHARMACY Medaus, Inc. Class II Terminated 20160720
SELENIUM 200MCG/ML (PF), 10ML Vials, MEDAUS PHARMACY Medaus, Inc. Class II Terminated 20160720
RIBOFLAVIN 10MG/ML (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY Medaus, Inc. Class II Terminated 20160720
PYRIDOXINE HCL 100MG/ML W/PRES (BENZYL ETOH 0.02%), 5ML Vials, MEDAUS PHARMACY Medaus, Inc. Class III Terminated 20160720
PYRIDOXINE HCL 100MG/ML (PF), In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY Medaus, Inc. Class II Terminated 20160720
PYRIDOXAL 50 MG/THIAMINE 50 MG/LIDOCAINE 1% NS (PF), 2ML Vials, MEDAUS PHARMACY Medaus, Inc. Class II Terminated 20160720
PROLINE 100MG/ML (PF), 5ML Vials, MEDAUS PHARMACY Medaus, Inc. Class II Terminated 20160720
PROCAINE 2% (PF), In a) 2ML Vials and b) 10ML Vials, MEDAUS PHARMACY Medaus, Inc. Class II Terminated 20160720
NIACINAMIDE 100 MG/ML (PF), In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY Medaus, Inc. Class II Terminated 20160720
NANDROLONE DEC 200MG/ML W/PRES. (BENZYL ETOH 10%), In a) 2ML Vials, b) 4ML Vials, and c) 5ML Vials, MEDAUS PHARMACY Medaus, Inc. Class II Terminated 20160720
NA ASCORBATE 500MG/ML NON-CORN (PF), In a) 10ML Vials, b) 50ML Vials, and c) 100ML Vials, MEDAUS PHARMACY Medaus, Inc. Class II Terminated 20160720
NA ASCORBATE 500MG/ML (PF), In a) 10ML Vials, b) 50ML Vials, and c) 100ML Vials, MEDAUS PHARMACY Medaus, Inc. Class II Terminated 20160720