Hazard Type

Sterility Issue Recalls

10,814 product recalls involving sterility issue. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

10,814Total Recalls
297Critical
67933.1MUnits Affected
All Recalls

Every Sterility Issue Recall

Sorted by most recent. Click any recall for full details and safety information.

10,814 recalls
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Fentanyl Citrate 2mcg/mL & Bupivacaine 0.125% in 0.9% Sodium Chloride 150 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceutica...
Drugs·105 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Morphine Sulfate (PF) 1mg/mL in 0.9% Sodium Chloride, 50 mL lntravia Bag IV USE ONLY, Rx Only, Compounded by PHARMAKON Pharmaceuticals, N...
Injectable Drugs·45 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Cefazolin 3GM Added to a 100 mL 0.9% Sodium Chloride Bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45...
Drugs·18 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Fentanyl Citrate 5 mcg/mL & Bupivacaine 0.06% in 0.9% Sodium Chloride, 60 mL BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals...
Drugs·100 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Cefazolin 1GM in Sterile Water, 10 ml BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0960-72
Drugs·1,675 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Magnesium Sulfate 50 GM in Lactated Ringers 500 mL bag; Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 4518...
Drugs·72 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
HYDROmorphone 1mg/mL in 0.9% Sodium Chloride 1 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, ...
Drugs·4,500 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Fentanyl Citrate 2mcg/mL & Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 100 mL bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville...
Drugs·20 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Midazolam HCI1mg/mL in 0.9% Sodium Chloride 100 mL fill in a 150 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noble...
Drugs·45 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Oxytocin 30 Units added to 0.9% Sodium Chloride in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, ...
Drugs·384 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Rocuronium 10 mg/mL, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0955-70
Drugs·1,925 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Bupivacaine HCI 0.25% in 0.9% Sodium Chloride, 500 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46...
Drugs·70 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Potassium Chloride 40 mEq Added to 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 460...
Drugs·40 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Sufentanil Citrate 0.4mcg/mL & Bupivacaine 0.1% in 0.9% Sodium Chloride 250 mL Intravia Bag, Rx Only, Compounded by PHARMAKON Pharmaceut...
Drugs·595 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Oxytocin 20 Units added to 0.9% Sodium Chloride in a 1000mL lntravia bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060...
Drugs·1,809 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
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 Pharmaceutical...
Drugs·725 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Cefazolin 2GM added to 5% Dextrose 50 mL USP, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0610-41
Drugs·1,450 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Ketamine 50mg/mL in 0.9% Sodium Chloride 1mL fill in 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 4606...
Drugs·200 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
HYDROmorphone HCI 0.2 mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 mL Monoject Syringe, Rx Only, Compounded by PHARMAKON Pharmaceutic...
Drugs·120 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Ketamine 20 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, N...
Drugs·175 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Succinylcholine Chloride 20 mg/mL, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0...
Drugs·2,175 affected·Apr 20, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Vancomycin 1750 mg in 270 mL 0.9% NS bag,FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Injectable Drugs·54 affected·Apr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Vancomycin 1000 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Injectable Drugs·59 affected·Apr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Ertapenem 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, ...
Injectable Drugs·16 affected·Apr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
0.9% Sodium Chloride a) 500 mL b) 2000 mL and c) 3000 mL bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little...
Injectable Drugs·6 affected·Apr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Ceftriaxone 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusio...
Injectable Drugs·39 affected·Apr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Remicade 600 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Injectable Drugs·1 affected·Apr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Nafcillin 3 grams in 277 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Injectable Drugs·7 affected·Apr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Cefazolin 6 grams in 292 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, Arkansas
Injectable Drugs·11 affected·Apr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
TPN 2, (amino acid 20%) 2000 ml bag (140), FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock Arkansas
Injectable Drugs·86 affected·Apr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Daptomycin 650 mg in 50 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Injectable Drugs·14 affected·Apr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Piperacillin-Tazobactam 10.125 grams/NS 307 mL BAG, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Injectable Drugs·14 affected·Apr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Piperacillin-Tazobactam 13.5 grams/NS 322 mL bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Injectable Drugs·53 affected·Apr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
1/2 Normal Saline 2000 mL + Sodium Acetate 80 mEq., FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Injectable Drugs·7 affected·Apr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Ascorbic Acid 500 mg (1 mL) Syringe, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Injectable Drugs·21 affected·Apr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
70% Ethanol-lock Solution, 2 mL Syringe, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Injectable Drugs·18 affected·Apr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Vancomycin 1250 mg in 250 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Injectable Drugs·84 affected·Apr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Ceftriaxone 2 gram Add-Vantage in 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Injectable Drugs·16 affected·Apr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Milrinone 200 mcg/mL in a) D5W-300 mL, b) D5W-400 mL, c) D5W-500 mL and d) D5W-600 mL Bags, FOR IV USE ONLY, Baptist Health Medical Towe...
Injectable Drugs·15 affected·Apr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Deferoxamine 2 grams/51 mL NS cassette, FOR SUBCUTANEOUS USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Drugs·5 affected·Apr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Sodium Chloride 0.9% 1000 mL with Electrolytes bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Injectable Drugs·7 affected·Apr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Meropenem 2 grams in 100 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Injectable Drugs·22 affected·Apr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Hydromorphone 2 mg/mL (500 mg in 250 mL NS) bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Injectable Drugs·3 affected·Apr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Water for Injection 1000 mL Bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock Arkansas
Injectable Drugs·7 affected·Apr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Piperacillin-Tazobactam 9 grams/NS 302 mL bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Injectable Drugs·4 affected·Apr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Vancomycin 1500 mg in 270 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Injectable Drugs·88 affected·Apr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
TPN 1, (amino acid 20%) 2000 ml bag (140), FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock Arkansas
Injectable Drugs·7 affected·Apr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Vancomycin 750 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Injectable Drugs·47 affected·Apr 18, 2016