FDA Drug Recalls

966 recalls · Class II, newest first

Apr 20, 2016 Class II · Moderate risk

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

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0189-02 D-1277-2016

Apr 20, 2016 Class II · Moderate risk

Promethazine 25 mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0187-41 D-1276-2016

Apr 20, 2016 Class II · Moderate risk

Promethazine 12.5mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0186-41 D-1275-2016

Apr 20, 2016 Class II · Moderate risk

Methohexital

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0180-72 D-1274-2016

Apr 20, 2016 Class II · Moderate risk

Promethazine 6.25 mg added to 0.9% Sodium Chloride 50 mL in 100 mL B/Braun PAB bag

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0177-41 D-1273-2016

Apr 20, 2016 Class II · Moderate risk

Norepinephrine 16 mg added to 0.9% sodium Chloride

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0174-02 D-1272-2016

Apr 20, 2016 Class II · Moderate risk

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

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0173-02 D-1271-2016

Apr 20, 2016 Class II · Moderate risk

Fentanyl Citrate 2mcg/mL & Bupivacaine 0.125% in 0.9% Sodium Chloride 150 mL Intravia bag

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0171-01 D-1270-2016

Apr 20, 2016 Class II · Moderate risk

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

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0148-48 D-1269-2016

Apr 20, 2016 Class II · Moderate risk

Adenosine 1mg/ml

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0146-47 D-1268-2016

Apr 20, 2016 Class II · Moderate risk

Midazolam

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0138-67 D-1267-2016

Apr 20, 2016 Class II · Moderate risk

Epinephrine

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0135-70 D-1266-2016

Apr 20, 2016 Class II · Moderate risk

Epinephrine 100mcg/mL injection in 0.9% Sodium Chloride 10 mL BD syringe

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0120-72 D-1265-2016

Apr 20, 2016 Class II · Moderate risk

Propofol1% 10mg/mL injection

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0119-73 D-1264-2016

Apr 20, 2016 Class II · Moderate risk

Fentanyl Citrate injection

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0118-41 D-1263-2016

Apr 20, 2016 Class II · Moderate risk

Hydromorphone HCl 1mg/ml injection in 0.9% Sodium Chloride

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0114-48 D-1262-2016

Apr 20, 2016 Class II · Moderate risk

Ceftriaxone 1GM injection in Sterile Water

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0106-72 D-1261-2016

Apr 20, 2016 Class II · Moderate risk

Succinylcholine Chloride 20 mg/mL injection

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0104-70 D-1260-2016

Apr 20, 2016 Class II · Moderate risk

Fentanyl Citrate 50 mcg/ml injection

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0100-69 D-1259-2016

Apr 20, 2016 Class II · Moderate risk

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

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0029-01 D-1258-2016

Apr 20, 2016 Class II · Moderate risk

Bupivacaine 1mg/mL injection in 0.9% Sodium Chloride 250 mL bag

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0019-02 D-1257-2016

Apr 20, 2016 Class II · Moderate risk

Phenylephrine 40 mcg/mL injection in 0.9% Sodium Chloride 10 mL syringe

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0011-72 D-1256-2016

Apr 18, 2016 Class II · Moderate risk

Vancomycin 2 grams in 540 mL 0.9% NS bags

Lack of Sterility Assurance.

Terminated Sterility / contamination Baptist Health Medical Towers Pharmacy and Infusion Services D-0948-2016

Apr 18, 2016 Class II · Moderate risk

Vancomycin 1 grams in 250 mL 0.9% NS bags

Lack of Sterility Assurance

Terminated Sterility / contamination Baptist Health Medical Towers Pharmacy and Infusion Services D-0947-2016

Apr 18, 2016 Class II · Moderate risk

Vancomycin 1750 mg in 270 mL 0.9% NS bag

Lack of Sterility Assurance

Terminated Sterility / contamination Baptist Health Medical Towers Pharmacy and Infusion Services D-0946-2016

Recalls by year

2026563
2025778
2024557
20231,122
20221,390
20211,152
2020930
20191,788
20181,681
20171,141
20161,199
20151,733
20141,309
20132,085
2012534
201134
20104
20072
20061