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
Cmc Enterprise Pharmacy
Sodium Citrate 4%, 40 mg/mL, 3 mL syringe, Flush Syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlott...
Drugs·40 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Magnesium Sulfate 1 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·2,162 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, N...
Drugs·118 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Vancomycin 1000 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·532 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Phenylephrine 20 mg NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·390 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
CeFAZolin 1 GM a) in NS 100 mL bag; b) 100 mg/mL (10 mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, C...
Drugs·150 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Diltiazem 250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·1,475 affected·Apr 12, 2019
High RiskFDA
Geistlich Pharma North America, Inc.
Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 1-2mm 0.5g, For single use only, Part Number 20126 - Product Usage: ...
Medical Devices·244,268 affected·Apr 12, 2019
High RiskFDA
Geistlich Pharma North America, Inc.
Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.25g, For single use only, Part Number 20115 - Product Us...
Medical Devices·244,268 affected·Apr 12, 2019
High RiskFDA
Bard Peripheral Vascular Inc
BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr. Bard Peripheral Vascular, Inc., ...
Surgical Devices·150 affected·Apr 12, 2019
High RiskFDA
Uromedica Inc.
ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through wh...
Medical Implants·11 affected·Apr 10, 2019
High RiskFDA
Customceutical Compounding
BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL 250MG/ML), 10 ML MULTIDOSE VIAL MDV INJ COMPOUNDED. Customc...
Drugs·19 affected·Apr 8, 2019
High RiskFDA
Customceutical Compounding
HCG (CHORIONIC GONADOTROPIN 1000 IU/ML PEP 25 mg/mL) inj 5 mL multidose vial compounded. Customceutical Compounding 4611 E. Shea Blvd. B...
Drugs·12 affected·Apr 8, 2019
High RiskFDA
Customceutical Compounding
Trimix HIGH (Papaverine HCl 30 mg/mL Phentolamine Mesylate 2 mg/mL Alprostadil 20 mcg/mL), 2 mL multidose vial MDV Inj. Compounded. Custo...
Drugs·3 affected·Apr 8, 2019
High RiskFDA
Customceutical Compounding
BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL 250MG/ML), 10 ML MULTIDOSE VIAL MDV INJ COMPOUNDED. Customc...
Drugs·32 affected·Apr 8, 2019
High RiskFDA
Customceutical Compounding
Test D (TESTOSTERONE CYPIONATE 200MG/ML VITAMIN D3 5,000IU/ML), 5 ML MULTIDOSE VIAL COMPOUNDED. Customceutical Compounding 4611 E. Shea ...
Supplements·8 affected·Apr 8, 2019
High RiskFDA
Customceutical Compounding
Lipoplex (METHIONINE 25 MG/ML INOSITOL 50 MG/ML CHOLINE CHLORIDE 50 MG/ML HYDROXOCOBALAMIN 500 MC/ML DEXPANTHENOL 50 MG/ML PYRIDOXINE HCL...
Drugs·16 affected·Apr 8, 2019
High RiskFDA
Customceutical Compounding
Glutathione 200mg/mL inj. a) 10 ML and b) 12 ML MULTIDOSE VIAL MDV Compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, ...
Drugs·4 affected·Apr 8, 2019
High RiskFDA
Customceutical Compounding
Test PROCYP (TESTOSTERONE CYPIONATE 200MG/ML TESTOSTERONE PROPIONATE 20MG/ML), 5 ML MULTIDOSE VIAL INJ COMPOUNDED. Customceutical Compoun...
Drugs·5 affected·Apr 8, 2019
High RiskFDA
Customceutical Compounding
Test D (TESTOSTERONE CYPIONATE 200MG/ML VITAMIN D3 5,000IU/ML), 5 ML MULTIDOSE VIAL COMPOUNDED. Customceutical Compounding 4611 E. Shea ...
Supplements·2 affected·Apr 8, 2019
High RiskFDA
Customceutical Compounding
TriMix MEDIUM (Papaverine HCL 21 mg/mL Phentolamine Mesylate 0.7 mg/mL Alprostadil 7 mcg/mL), 2 mL multidose MDV Inj. Compounded. Customc...
Drugs·0 affected·Apr 8, 2019
High RiskFDA
Delfi Medical Innovations, Inc.
Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003. Rx Only,...
Medical Devices·59 affected·Apr 3, 2019
High RiskFDA
Anderson Compounding Pharmacy, Inc. Dba Anderson Compounding Pharmacy
HCG 4,100 Units/vial Injection, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Injectable Drugs·1 affected·Apr 2, 2019
High RiskFDA
Anderson Compounding Pharmacy, Inc. Dba Anderson Compounding Pharmacy
Heparin 2 mL/Lidocaine 2%-10 mL/Sodium Bicarbonate 8.4%-5mL/ Sterile Water 10 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Brist...
Drugs·6 affected·Apr 2, 2019
High RiskFDA
Anderson Compounding Pharmacy, Inc. Dba Anderson Compounding Pharmacy
Heparin 10 mL/Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/per 70 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Drugs·12 affected·Apr 2, 2019
High RiskFDA
Anderson Compounding Pharmacy, Inc. Dba Anderson Compounding Pharmacy
HCG 23 Day, 2876 Units/4.6 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Drugs·31 affected·Apr 2, 2019
High RiskFDA
Anderson Compounding Pharmacy, Inc. Dba Anderson Compounding Pharmacy
Heparin 10 mL/Marcaine 0.25% 20 mL/Sodium Bicarbonate 40 mL/Normal Saline 5 mL per 75 mL, 60 mL Syringe, Anderson Compounding Pharmacy 31...
Drugs·0 affected·Apr 2, 2019
High RiskFDA
Anderson Compounding Pharmacy, Inc. Dba Anderson Compounding Pharmacy
Vitamin D3 200,000 IU/mL Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Injectable Drugs·4 affected·Apr 2, 2019
High RiskFDA
Anderson Compounding Pharmacy, Inc. Dba Anderson Compounding Pharmacy
DMSO 50% 60 mL/Heparin 1 mL/ Sodium Bicarbonate 60 mL/ Solu-Cortef 100 mg, 41 mL syringe, Anderson Compounding Pharmacy 310 Bluff City Hw...
Drugs·1 affected·Apr 2, 2019
High RiskFDA
Anderson Compounding Pharmacy, Inc. Dba Anderson Compounding Pharmacy
Heparin 10 mL/ Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/ Normal Saline 5 mL, 60 mL Syringe, Anderson Compounding Pharmacy 310 Bl...
Drugs·1 affected·Apr 2, 2019
High RiskFDA
Anderson Compounding Pharmacy, Inc. Dba Anderson Compounding Pharmacy
Heparin 20,000 U/Lidocaine 2% 10 mL/Sodium Bicarbonate 8.4% 10 mL/Sterile Water 5 mL, 27 mL Syringe, Anderson Compounding Pharmacy 310 Bl...
Drugs·2 affected·Apr 2, 2019
High RiskFDA
Anderson Compounding Pharmacy, Inc. Dba Anderson Compounding Pharmacy
Sermorelin 0.3 mg/0.5 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Drugs·22 affected·Apr 2, 2019
High RiskFDA
Anderson Compounding Pharmacy, Inc. Dba Anderson Compounding Pharmacy
Prostaglandin Quad with Atropine 10:30:1:0.15, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Drugs·5 affected·Apr 2, 2019
High RiskFDA
Anderson Compounding Pharmacy, Inc. Dba Anderson Compounding Pharmacy
Prostaglandin Tri-Mix 20:30:1, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Drugs·58 affected·Apr 2, 2019
High RiskFDA
Anderson Compounding Pharmacy, Inc. Dba Anderson Compounding Pharmacy
Prostaglandin Tri-Mix 20:25:1 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Injectable Drugs·0 affected·Apr 2, 2019
High RiskFDA
Anderson Compounding Pharmacy, Inc. Dba Anderson Compounding Pharmacy
Serum Tears 50% Ophthalmic Drops, 1 mL Dropper, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Ophthalmic Drugs·0 affected·Apr 2, 2019
High RiskFDA
Anderson Compounding Pharmacy, Inc. Dba Anderson Compounding Pharmacy
Bacitracin 3000U/30 mL Irrigation, 30 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Drugs·2 affected·Apr 2, 2019
High RiskFDA
Anderson Compounding Pharmacy, Inc. Dba Anderson Compounding Pharmacy
Morphine Sulfate 5 mg/3mL Inhalation, 3 mL Vials, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Drugs·60 affected·Apr 2, 2019
High RiskFDA
Anderson Compounding Pharmacy, Inc. Dba Anderson Compounding Pharmacy
HCG 11,000 Units, 30 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Drugs·9 affected·Apr 2, 2019
High RiskFDA
Anderson Compounding Pharmacy, Inc. Dba Anderson Compounding Pharmacy
HCG 23 Day Injection Extra Strength, vials, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN 1-800-263-8890
Injectable Drugs·14 affected·Apr 2, 2019
High RiskFDA
Anderson Compounding Pharmacy, Inc. Dba Anderson Compounding Pharmacy
Prostaglandin 40 mcg/mL, Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Drugs·6 affected·Apr 2, 2019
High RiskFDA
Anderson Compounding Pharmacy, Inc. Dba Anderson Compounding Pharmacy
Prostaglandin Tri-Mix 2.5:7.5:0.25 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Injectable Drugs·0 affected·Apr 2, 2019
High RiskFDA
Anderson Compounding Pharmacy, Inc. Dba Anderson Compounding Pharmacy
Serum Tears 20% Drops, 1 mL Droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Drugs·40 affected·Apr 2, 2019
High RiskFDA
Anderson Compounding Pharmacy, Inc. Dba Anderson Compounding Pharmacy
Gentamicin 250 mg/1000 mL Irrigation, 1000 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Drugs·4 affected·Apr 2, 2019
High RiskFDA
Anderson Compounding Pharmacy, Inc. Dba Anderson Compounding Pharmacy
Methylcobalamin 3000 mcg/mL Injection Solution, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Injectable Drugs·0 affected·Apr 2, 2019
High RiskFDA
Anderson Compounding Pharmacy, Inc. Dba Anderson Compounding Pharmacy
HCG 20 Day Injection, 2625 Units/4 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Injectable Drugs·217 affected·Apr 2, 2019
High RiskFDA
Anderson Compounding Pharmacy, Inc. Dba Anderson Compounding Pharmacy
Gentamicin 160 mg/1000 mL Sterile Water for Irrigation,1000 mL Bottle, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Drugs·0 affected·Apr 2, 2019
High RiskFDA
Anderson Compounding Pharmacy, Inc. Dba Anderson Compounding Pharmacy
Estrone 5mg/mL Oil Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Injectable Drugs·0 affected·Apr 2, 2019