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
Natures Pharmacy & Compounding Center
Gentamycin 80mg/1000cc 0.9% NS
Drugs·0 affected·Nov 1, 2013
High RiskFDA
Natures Pharmacy & Compounding Center
Idoxuridine 0.1% Ophthalmic
Ophthalmic Drugs·0 affected·Nov 1, 2013
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Acetabular Pressurizer; single use and six units per box. The Acetabular Pressurizer 0206-522-000 is an accessory to the Advanced Cem...
Medical Implants·87 affected·Nov 1, 2013
High RiskFDA
National Enzyme Co
9326 Kirkman Bacterial Bio 6, packaged in unlabeled 60-capsule bottles (SKU 53666);
Food·7,053 affected·Oct 30, 2013
High RiskFDA
Orthofix, Inc
Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., RX Only The Azure Anter...
Medical Implants·4,172 affected·Oct 29, 2013
High RiskFDA
Centurion Medical Products Corporation
Centurion Sterile # 84 Rubber Bands Reorder EB84, Caution: This product contains natural rubber latex which may cause allergic reaction...
Medical Devices·500 affected·Oct 28, 2013
High RiskFDA
Civco Medical Instruments Inc
Civco Belly Board, Reusable non-sterile carbon fiber belly board with cushion, REF 125012, packaged 1 per box. Product Usage: This d...
Medical Devices·138 affected·Oct 25, 2013
High RiskFDA
Civco Medical Instruments Inc
Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion, REF 126000, packaged 1 per box. Product Usage: Thi...
Medical Devices·2 affected·Oct 25, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis***STRAI...
Medical Implants·9 affected·Oct 23, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
0.9% Sodium chloride a) DT-0.9% Sodium chloride* 100 mL Drug Study - IV 100 mL Injectable, b) DT-0.9% Sodium Chloride* 100 mL Drug Study ...
Injectable Drugs·800 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Combo Eye Gel, HF COMBO EYE GEL* (cyclopentolate 2%, tropicamide 1%, diclofenac sodium 0.1%, ciprofloxacin 0.3%, phenylephrine 10%, lidoc...
Topical Drugs·38 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Calcium Chloride* PF 500 mg/mL pref syringe, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Drugs·8,090 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
TRANEXAMIC ACID* 2 g/75 mL SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Drugs·3,000 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Acetylcysteine (PF) 20 % Opthalmic, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Drugs·20 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Glutathione PF, 60 mg/mL inhalation, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Drugs·126 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Bevacizumab, (repackaged) in a) 0.11 mL and b) 0.06 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI...
Drugs·2,801 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
TROPICAMIDE* 1% OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Ophthalmic Drugs·5 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
DT- Tranexamic Acid* 2 gm/100 mL Drug Study -IV 100 mL injectable, DT-, DT-Tranexamic Acid* 2 gm/100 mL-Drug Study-Topical 100 mL Rx only...
Injectable Drugs·600 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
TESTOS CYPIONATE* IN OIL 100 mg/mL INJECTABLE, TESTOS CYPIONATE* IN OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding P...
Injectable Drugs·33 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
NALTREXONE* MDV 1MG/ML INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Injectable Drugs·100 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
METHOCARBAMOL (REPACK) 100 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Injectable Drugs·20 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Papaverine HCL, 30 mg/mL injectable, also labeled as (10 mL) and (2 mL), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayett...
Injectable Drugs·1,351 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
QUAD MIX* 0.05 mg/25 mg/2 mg/25 mcg/mL INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/50 mcg INJE...
Injectable Drugs·86 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
GLYCERIN-CHROMATED (W/V)* 72% INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Injectable Drugs·210 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Neomycin Sulfate* ophthalmic solution, 333 mg/mL, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyo...
Ophthalmic Drugs·5,582 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
HYDROXOCOBALAMIN* 10,000 mcg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Injectable Drugs·70 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Phenol, 6%, Injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Injectable Drugs·11 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
METHYLCOBALAMIN * 10 mg/mL INJECTABLE, METHYLCOBALAMIN * UD/PF 25 mg/mL INJECTABLE, METHYLCOBALAMIN* 1000 mcg/mL INJECTABLE, METHYLCOBALA...
Injectable Drugs·726 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Sodium tetradecyl SO4, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Injectable Drugs·100 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
TESTOS CYPIONATE* IN OLIVE OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Injectable Drugs·17 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
EDETATE DISODIUM* (0.05M) 1.7% OPHTH SOL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Drugs·30 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Ceftazidime, 22.5 mg/ml (ophthalmic), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Ophthalmic Drugs·44 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Cyanocobalamin, 1000 mcg/ml; injectable, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Injectable Drugs·180 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
TRIPLE MIX* 15 mg/1 mg/20 mcg/mL INJECTABLE, TRIPLE MIX* 30 mg/1 mg/20 mcg/mL INJECTABLE (papaverine hydrochloride, phentolamine, prosta...
Injectable Drugs·44 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
FLUOROURACIL* PF 50 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Injectable Drugs·4 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
POTASSIUM PHOSPHATE* PF 4.4 MEQ (3MM)/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Injectable Drugs·600 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
DEXAMETHASONE NAPO4* PF 4MG/ML SOLUTION, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Drugs·70 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Aluminum Potassium Sulfate Sterile powder, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Drugs·160 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Multitrace-4 pediatric injection ( zinc sulfate usp granular heptahydrate, cupric sulfate pentahydrate usp, manganese sulfate monohydrate...
Injectable Drugs·186 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Sodium Thiosulfate PF, 10 % injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Injectable Drugs·180 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
VIGAMOX (moxifloxacin)* IN BSS (0.15 %) 0.75 mg/0.5 mL PREF SYRINGE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, ...
Drugs·204 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Papav/Phentol/PG E1, 30 mg/1 mg/20 mcg/mL, injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI ...
Injectable Drugs·35 affected·Oct 19, 2013
CriticalFDA
Specialty Medicine Compounding Pharmacy, P.c.
Dextrose* Vial In Sterile Water, 50%, 50 mL Single Dose Vial, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Ly...
Drugs·1,000 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
SODIUM PHOSPHATE* PF 3MMOL/mL INJECTABLE, SODIUM PHOSPHATE* PF(15 mL) 3MMOL/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharma...
Injectable Drugs·9,200 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Phenylephrine/Tropicamide 2.5 %/1 % ophthalmic solution, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, M...
Ophthalmic Drugs·6 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
LIDOCAINE/SODIUM CHL* 0.4 %/18 % INJECTABLE; all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI...
Injectable Drugs·65 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
SODIUM HYDROXIDE (BAC.STATIC) 10% SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Drugs·10 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
QUAD MIX* IN NACL (1.8/0.2/0.02)mg/18 mcg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, M...
Injectable Drugs·15 affected·Oct 19, 2013