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
Oregon Compounding Centers, Inc. Dba Creative Compounds
BEVACIZUMAB/DEXAMETHASONE, 1.25/0.5 mL, Injectable, 0.05 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070.
Injectable Drugs·2 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
TOBRAMYCIN, 480mg/1000 mL, solution for irrigation, 500 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070
Drugs·1,000 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.44mg/0.64mg/5.8mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·10 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
HYDROXOCOBALAMIN-preservative free (B12), 1mg/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·58 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
VITAMIN B COMPLEX (PRES) injectable, 100mg, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
Injectable Drugs·490 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
PYRIDOXINE HCL, with preservative, 100 mg/mL, injectable, 30 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·660 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
MITOMYCIN, 0.3mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·8 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
PAPAVERINE/PHENTOLAMINE/ALPROSTADIL, 26.5mg/0.98mg/58.9mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·15 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
ALPROSTADIL/LIDOCAINE HCL, 20mcg/5mg/mL, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
Drugs·5 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
GLUTARALDEHYDE BUFFERED (POTASSIUM PHOSPHATE), solution for irrigation, 250 mL glass bottle, RX, Creative Compounds, Wilsonville, OR 97070
Drugs·250 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
HYDROXOCOBALAMIN- preservative (B12), 1mg/mL, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·570 affected·Oct 6, 2014
High RiskFDA
Hospira Inc.
Vancomycin Hydrochloride for Injection, USP, 1 g Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira Inc.,...
Injectable Drugs·90,600 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
OMNIPAQUE, 300mgI/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·680 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
PREDNISOLONE Sodium Phosphate, 1%, Ophthalmic, 1 mL plastic dropper bottle, RX, Creative Compounds, Wilsonville, OR 97070
Ophthalmic Drugs·10 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
DEXAMETHASONE (AS SOD PHOS), 24 mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·4 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
TESTOSTERONE CYPIONATE (SESAME OIL/CMPD), 200mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·85 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
TRIESENCE, 8mg/2.0mL, Injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·2 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
ASCORBIC ACID (B), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
Injectable Drugs·2,500 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
ASCORBIC ACID (with Preservative), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
Injectable Drugs·7,900 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
MITOMYCIN, 0.2mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·5 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
METHYCOBALAMIN, preservative, 1mg/mL, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·1,320 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
GANCICLOVIR, preservative free, 0.2mg/0.05mL, injectable, 0.1 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·20 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
LIDOCAINE HCL (REPKG-STERILE), 4%, solution for irrigation, 5 mL, 6 mL, and 7 mL plastic dropper bottle, RX, Creative Compounds, Wilsonvi...
Drugs·49 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
CHORIONIC GONADOTROPIN, 4000 Units, sterile powder for reconstitution, glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Drugs·145 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
HYALURONIDASE, 240 u/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·10 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
ESTRADIOL CYPIONATE (COMPOUNDED/GRAPESEED OIL), 5 mg/mL, injectable, 1 ml glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·4 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
VANCOMYCIN, 1mg/0.1mL, injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·12 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
DEXPANTHENOL with preservative, 250 mg/mL, injectable, 30 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·210 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
GENTAMICIN SULFATE, 480mg/1000mL, solution for irrigation, 300 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070
Drugs·300 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
METHYCOBALAMIN, preservative free, 1mg/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·516 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.16mg/0.57mg/19.45mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·103 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
COPPER (SULF), 0.4 mg/mL, injectable, 20 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·600 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
CHORIONIC GONADOTROPIN, 5000 Units, sterile powder for reconstitution, glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Drugs·117 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
DMPS-preservative free, 50 mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·280 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
PAPAV HCL/PHENTOL/PROSTAGL, 12mg/1mg/10mcg, injectable, 1.25 mL glass vial or 1.7 ml glass vial, RX, Creative Compounds, Wilsonville, OR ...
Injectable Drugs·25 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
PAPAVERINE HCL/PHENTOLAMINE MES/ALPROSTADIL, 22mg/0.8mg/8mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·10 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
CALCIUM CHLORIDE (COMPOUND), 100 mg/mL, Injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·580 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
GENTAMICIN SULFATE, 100mg/1000mL, solution for irrigation, 400 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070
Drugs·800 affected·Oct 6, 2014
High RiskFDA
Hospira Inc.
Vancomycin Hydrochloride for Injection, USP, 500 mg Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira, I...
Injectable Drugs·200 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
AVASTIN, 1.25mg/0.5mL, injectable, 0.05 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070.
Injectable Drugs·5,483 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
PAPAVERINE HCL/PHENTOLAMINE/ALPROSTADIL, 21.82mg/0.91mg/45mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·43 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
SODIUM CHLORIDE INHALATION, 7%, Solution for inhalation, 3 mL plastic vial, RX, Creative Compounds, Wilsonville, OR 97070
Drugs·180 affected·Oct 6, 2014
High RiskFDA
Zimmer, Inc.
Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis component.
Medical Implants·352 affected·Oct 2, 2014
High RiskFDA
Hospira Inc.
Hydromorphone Hydrochloride Injection, USP, 10 mg/mL, Rx only, packaged in a) 1 mL Single-dose Vial (NDC 0703-0110-01), packaged in 10 x ...
Injectable Drugs·145,600 affected·Oct 1, 2014
High RiskFDA
Masimo Corporation
Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of ...
Respiratory Devices·21,754 affected·Sep 30, 2014
High RiskFDA
Biomet, Inc.
Green Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The...
Medical Devices·12 affected·Sep 26, 2014
High RiskFDA
Sterilmed, Inc.
Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.
Surgical Devices·22 affected·Sep 24, 2014
High RiskFDA
C P Medical, Inc.
Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. Product is labeled sterile. The product is s...
Surgical Devices·74 affected·Sep 22, 2014