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
Key Pharmacy And Compounding Center
MAGNESIUM SO4 10ML MDV 50% INJ, Injection, 50%, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Injectable Drugs·3 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
TRI MIX 10/15/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/15mg/1mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compound...
Injectable Drugs·2 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
HYDROXO-B12 30ML PBF MDV (CALIF) 1MG/ML INJ, Injection, 1mg/mL, Rx only, 30 mL Glass/Multiple Dose vial, Prepared by Key Compounding Phar...
Injectable Drugs·2 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
HYDROXO-B12 10ML PBF MDV 5MG/ML INJ, 5mg/mL, Rx only, 10 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy HYDROXO-...
Drugs·8 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
GSH/NAC INH 2ML PV 60/100MG/ML SOLN, Inhalation Solution, 60mg/100mg/mL, Rx only, 5mL Plastic/Single Dose vial, Prepared by Key Compoundi...
Drugs·50 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
GSH/NAC INH PV 150/50MG/ML SOLN, Inhalation Solution, 150mg/50mg/mL, Rx only, 4mL Plastic/Multiple Dose vial, Prepared by Key Compounding...
Drugs·180 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
TRI MIX 20/30/2 5ML MDV MCG/MG/MG/1ML INJ, Injection, 20mcg/30mg/2mg/mL, Rx only, 5 mL Glass/Multiple Dose vial , Prepared by Key Compou...
Injectable Drugs·17 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
PGE1 MDV 20MCG/ML INJ, Injection, 20mcg/mL, Rx only, packaged in a 5 mL, 10mL, and 15 mL Glass/Multiple Dose vials, Prepared by Key Compo...
Injectable Drugs·5 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
TRI MIX 40/30/4 5ML MDV MCG/MG/MG/ML INJ, Injection, 40mcg/30mg/4mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compoundi...
Injectable Drugs·5 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
IRON SPECIAL 5ML MDV 60/10MG/5MCG/ML INJ, Injection, 60mg/1mg/5mcg/mL, Rx only, 5mL Glass /Multiple Dose vial, Prepared by Key Compoundin...
Injectable Drugs·2 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
FOLIC ACID 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/Single Dose vial, Prepared by Key Compounding Pharmacy
Injectable Drugs·20 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
FERR GLUC/PROCAINE 10ML MDV 60/10MG/ML INJ, Injection, 60mg/10mg/mL, Rx only, 10 mL glass/Multiple Dose vial, Prepared by Key Compoundin...
Injectable Drugs·1 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
CHOL/IN/ME(L)/B6 10ML MDV 50/50/25/0.1MG/ML INJ, Injection, 50mg/50mg/25mg/0.1mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by...
Injectable Drugs·1 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
PAPAVERINE/PHENT 5ML MDV 30/0.5MG/ML INJ, Injection, 30/0.5mg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Phar...
Injectable Drugs·4 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
GLUTATHIONE INH *PV* 200MG/ML SOLN, Inhalation Solution, 200mg/mL, Rx only, 4mL Plastic/Multiple Dose vial, Prepared by Key Compounding P...
Drugs·240 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
TRI MIX 20/30/0.5 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/30mg/0.5mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Comp...
Injectable Drugs·2 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
PROCAINE HCL SDV 2% INJ, Injection, 2%, Rx only, packaged in 10mL and 50 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
Injectable Drugs·9 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
DMPS ACID *5ML* SDV 50MG/ML INJ, Injection, 50mg/ml, Rx only, 5 mL glass/ Single Dose vial, Prepared by Key Compounding Pharmacy
Injectable Drugs·214 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
FOLINIC ACID MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 5 mL and10 mL glass/ Multiple Dose vial, Prepared by Key Com...
Injectable Drugs·3 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
TRI MIX 45.45/27.27/0.45 5ML MDV MCG/MG/MG/ML INJ, Injection, 45.45mcg/27.27mg/0.45mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepare...
Injectable Drugs·1 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
TRI MIX 40/30/2 5ML MDV MCG/MG/MG/ML INJ, Injection, 40mcg/30mg/2mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compoundi...
Injectable Drugs·2 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
FOLINIC ACID MDV INJ, Injection, 10 mg/mL, Rx only, packaged in 2mL and 10 mL glass/Multiple Dose vials, Prepared by Key Compounding Phar...
Injectable Drugs·12 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
HYDROXO-B12 PBF MDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, packaged in a 5 mL and 30 mL Glass/ Multiple Dose vials, Prepared by Key Co...
Injectable Drugs·27 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
SODIUM BICARB 50ML MDV 8.4% (2 MOSMOL/ML) INJ, Injection, 8.40%, Rx only, 5mL Glass/Multiple Dose via, Prepared by Key Compounding Phar...
Injectable Drugs·2 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
PGE1/CPZ 5ML MDV 20MCG/1MG/ML INJ, Injection, 20mcg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Injectable Drugs·2 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
METHYL-B12 5ML MDV (CALIF) 1MG/ML INJ, Injection, 1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Injectable Drugs·26 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
TRI MIX 13/30/0.8 5ML MDV MCG/MG/MG/ML INJ, Injection, 13mcg/30mg/0.8mg/mL, RX only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compo...
Injectable Drugs·1 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
TRI MIX 10/30/0.5 *5ML* MDV MCG/MG/MG/ML INJ, Injection,10mcg/30mg/0.5mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Com...
Injectable Drugs·200 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
CO-Q-10 OIL 20ML MDV (CALIF) 25MG/ML INJ, Injection, 25mg/mL, Rx only, 20mL Glass /Multiple Dose vial, Prepared by Key Compounding Phar...
Injectable Drugs·1 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
TRI MIX 6/18/0.6 5ML MDV MCG/MG/MG/ML INJ, Injection, 6mcg/18mg/0.6mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compoun...
Injectable Drugs·2 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
PGE1 5ML MDV INJ, Injection, 40mcg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Injectable Drugs·2 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
VIT C/GSH 1.25%-1.25% OPHTH, Ophthalmic, 1.25%, Rx only, 15 mL Plastic/ Multiple Dose bottle, Prepared by Key Compounding Pharmacy
Ophthalmic Drugs·10 affected·Apr 18, 2017
High RiskFDA
Key Pharmacy And Compounding Center
SODIUM CHLORIDE INH PF GV 0.9% SOLN, Inhalation Solution, 0.90%, Rx only, 5mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
Drugs·75 affected·Apr 18, 2017
High RiskFDA
Zimmer Biomet, Inc.
Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin
Medical Devices·4,238 affected·Apr 13, 2017
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only
Medical Devices·36 affected·Apr 13, 2017
High RiskFDA
Medline Industries, Inc.
Art-Line Surgery Pack-LF, STERILE, 40 packs each per case.
Medical Devices·3,000 affected·Apr 12, 2017
High RiskFDA
Medline Industries, Inc.
PICC Tray, STERILE, 12 packs each per case.
Medical Devices·144 affected·Apr 12, 2017
High RiskFDA
B Braun Medical Inc
CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units per case)
Medical Devices·417,600 affected·Apr 10, 2017
High RiskFDA
Isomeric Pharmacy Solution, Llc
Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric ...
Injectable Drugs·851 affected·Apr 6, 2017
High RiskFDA
Isomeric Pharmacy Solution, Llc
Triamcinolone Diacetate 40 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT...
Injectable Drugs·1,951 affected·Apr 6, 2017
High RiskFDA
Isomeric Pharmacy Solution, Llc
Testosterone Cypionate 200 mg/mL, Testosterone Propionate 20 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solut...
Injectable Drugs·2,156 affected·Apr 6, 2017
High RiskFDA
Isomeric Pharmacy Solution, Llc
Triamcinolone Acetonide 40 mg/mL, Lidocaine HCl 10 mg/mL , 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 240...
Injectable Drugs·2,335 affected·Apr 6, 2017
High RiskFDA
Isomeric Pharmacy Solution, Llc
Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2...
Injectable Drugs·4,001 affected·Apr 6, 2017
High RiskFDA
Isomeric Pharmacy Solution, Llc
Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalmic) Drops in a bottle, Rx Only, Isomeric Pharmacy Solutio...
Ophthalmic Drugs·5,165 affected·Apr 6, 2017
High RiskFDA
Isomeric Pharmacy Solution, Llc
Methylprednisolone Acetate 80 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2...
Injectable Drugs·2,352 affected·Apr 6, 2017
High RiskFDA
Bausch & Lomb Surgical, Inc.
SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the folding and delivering of the LI61AO, LI61AOV, or LI61SE 3-piece ...
Medical Devices·0 affected·Apr 5, 2017
High RiskFDA
Smiths Medical Asd Inc.
Jelco, Hypodermic needle Pro¿ needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB 5021, Rx Only, Sterile EO.
Medical Devices·736,000 affected·Apr 4, 2017
High RiskFDA
Cell Distributors
Refresh Tears (Carboxymethylcellulose Sodium Solution) 0.5%, Lubricant Eye Drops, Sterile packaged as 1) two 15 mL bottles, USPC Code 784...
Ophthalmic Drugs·2,634 affected·Apr 3, 2017