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
Sca Pharmaceuticals, Llc
Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·1,882 affected·Jun 14, 2018
High RiskFDA
Sca Pharmaceuticals, Llc
Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume 125 mL) (125 mg), SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·2,869 affected·Jun 14, 2018
High RiskFDA
Sca Pharmaceuticals, Llc
Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·451 affected·Jun 14, 2018
High RiskFDA
Sca Pharmaceuticals, Llc
Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·400 affected·Jun 14, 2018
High RiskFDA
Sca Pharmaceuticals, Llc
Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syringe, SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·440 affected·Jun 14, 2018
High RiskFDA
Sca Pharmaceuticals, Llc
Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·492 affected·Jun 14, 2018
High RiskFDA
Sca Pharmaceuticals, Llc
Norepinephrine Bitartrate 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·2,268 affected·Jun 14, 2018
High RiskFDA
Sca Pharmaceuticals, Llc
Norepinephrine Bitartrate 16 mg (64 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·1,397 affected·Jun 14, 2018
High RiskFDA
Sca Pharmaceuticals, Llc
Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag (200 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·0 affected·Jun 14, 2018
High RiskFDA
Sca Pharmaceuticals, Llc
Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL 0.0625% in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·179 affected·Jun 14, 2018
High RiskFDA
Sca Pharmaceuticals, Llc
Phenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·451 affected·Jun 14, 2018
High RiskFDA
Sca Pharmaceuticals, Llc
Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·196 affected·Jun 14, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg, 0.9% Sodium Chloride, USP QS 250 mL). Volume 250 mL. Single dose Cassette. For: Parklan...
Drugs·20 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
fentaNYL (10 mcg per mL) in 0.95 Sodium Chloride, USP QS 1mL. Volume 1mL. Single dose Syringe. For: Hunt Regional Medical Center, By: Adv...
Drugs·120 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
ePHEDrine Sulfate, USP 50 mg in 0.9% Sodium Chloride, USP QS 10mL. 50 mg/10 mL (5 mg per mL). Volume 10 mL Single dose syringe. Avella ...
Drugs·225 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
Midazolam 0.5mg/mL (Midazolam HCL (USP) 50 mg, 0.9% Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. For: Coral Gables H...
Oral Drugs·220 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 30 mg, 0.9% Sodium Chloride (USP) QS 30 mL) Volume: 30mL. Single dose syringe. Avella of H...
Drugs·480 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
ceFAZolin 2 gm in NS 100mL. ceFAZolin Sodium (USP) 2gm, 0.9% Sodium Chloride (USP) 100mL. Volume 110 mL. Single dose bag. Avella of Houst...
Drugs·2,500 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
ePHEDrine Sulfate, USP 50mg in 0.9% Sodium Chloride USP QS 10mL. 50 mg/10 mL (5 mg/mL). Volume: 10 mL. Single dose syringe. Avella of Ho...
Drugs·500 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
PHENYLephrine 40 mg (PHENYLephrine HCL (USP) 40 mg, 5%Dextrose Inj., USP 250 mL) Volume: 254 mL. Single dose bag. Avella of Houston, 9265...
Drugs·200 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
NORepiNEPHrine 8 mg (norepinephrine Bitartrate (USP) 8 mg added to 5% Dextrose Inj. (USP) 250 mL. (Concentration 32 mcg/mL) Volume: 258 m...
Drugs·4,280 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr. H...
Drugs·850 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
HEPARIN 25,000 Units in 5% Dextrose (Heparin Sodium, USP 25,000 Units, 5% Dextrose Inj., USP 250 mL) Volume: 255 mL. Single dose bag. Ave...
Drugs·240 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
MORphine 150 mg (Morphine Sulfate, USP 150mg in 0.9% Sodium Chloride, USP QS 30mL). Volume 30 mL. Single dose syringe. Avella of Houston,...
Drugs·740 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
HEPARIN 12,500 Units in 5% Dextrose. (Heparin Sodium, USP 12,500 Units, 5% Dextrose Inj., USP 250 mL) Volume: 252.5 mL. Single dose bag. ...
Drugs·900 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL. Volume 5 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Ho...
Drugs·10,500 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
MAGnesium 1gm in NS 100 mL (MAGnesium SULfate (USP) 1 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 102 mL. Single dose bag. For: Salt ...
Drugs·25 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
Midazolam 1 mg/mL (Midazolam HCL (USP) 100 mg, Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. Avella of Houston, 9265 K...
Drugs·1,860 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
PHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg, 5% Dextrose (USP) 250 mL) Volume: 252 mL. Single dose bag. For: Vidant Medical Center...
Drugs·120 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL Single dose bag. Avella...
Drugs·1,290 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
MAGnesium 2gm in NS 100 mL (MAGnesium SULfate (USP) 2 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 104 mL. Single dose bag. For: Deser...
Drugs·175 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
fentaNYL 5 mcg Citrate, USP 5 mcg in 0.9% Sodium Chloride, USP QS 0.5mL. (10 mcg per mL) 5 mcg in 0.5 mL. Volume: 0.5 mL. Single dose s...
Drugs·100 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
PHENYLephrine 10 mg (PHENYLephrine HCL (USP) 10mg, 0.9% Sodium Chloride (USP) 250 mL. Volume: 251 mL Single dose bag. For: Redlands Commu...
Drugs·40 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
MORphine 1 mg/mL (Morphine Sulfate, USP 250mg, 0.9% Sodium Chloride, USP 250 mL). Volume 255 mL. Single dose bag. Avella of Houston, 9265...
Drugs·130 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
EPINEPHrine (USP) 4 mg, 5% Dextrose For Inj. (USP) 250 mL Volume: 254 mL single dose bag. For: Peninsular Regional Medical Center. By: Ad...
Drugs·420 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
Midazolam 1 mg/mL (Midazolam HCL USP 30 mg, 0.9% Sodium Chloride, USP QS 30 mL) Volume: 30 mL. Single dose syringe. For: Methodist Willow...
Drugs·0 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
MORphine 1 mg/mL (Morphine Sulfate, USP 100mg, 0.9% Sodium Chloride, USP QS 100 mL). Volume 100 mL. Single dose bag. Avella of Houston, 9...
Drugs·1,500 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 50 mg, 0.9% Sodium Chloride (USP) QS 50 mL) Volume: 50mL. Single dose syringe. Avella of H...
Drugs·275 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
fentaNYL 3 mcg/mL, 0.1% Bupivacaine, Fentanyl Citrate, USP 750 mcg, Bupivacaine HCL PF, USP, 250 mg, 0.9% Sodium Chloride, USP QS 250 mL....
Drugs·15 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
MAGnesium 4gm in NS 100 mL (MAGnesium SULfate (USP) 4 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 108 mL. Single dose bag. For: Gasto...
Drugs·100 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
HEPARIN 1,000 Units in NS 250mL. (Heparin Sodium, USP 1,000 Units, 0.9% Sodium Chloride, USP 250 mL) Volume: 251 mL. Single dose bag. For...
Drugs·40 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
fentaNYL 2 mcg/mL, 0.125% ROPivacaine, Fentanyl Citrate, USP 300 mcg, Ropivacaine HCL PF, USP 187.5 mg, 0.9% Sodium Chloride, USP QS 150...
Drugs·100 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
NORepiNEPHrine 16 (NORepiNEPHrine Bitartrate (USP) 16 mg, 5% Dextrose Inj. (USP) 250 mL. Volume: 266 mL. Single dose bag. Avella of Houst...
Drugs·520 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
0.2% ROPivacaine - OnQ Pump, (ROPivacaine HCL (USP) 1100mg, 0.9% Sodium Chloride (USP) QS 550 ml, single dose pump. For: Vidant Medical C...
Drugs·40 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
ePHEDrine 50mg, 50 mg/10 mL (5 mg per mL) (Ephedrine Sulfate, USP 50mg in 0.9% Sodium Chloride, USPQS 10mL. 10 mL-Sterile use dose syring...
Drugs·5,400 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 5% Dextrose Inj. (USP) 250 mL (Concentration 16 mcg/mL) Volume: 254 mL S...
Drugs·2,280 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
HYDROmorphone 0.2mg/mL. (Hydromorphone HCL (USP) 20 mg, 0.9% Sodium Chloride (USP) QS 100 mL) Volume: 100mL. Single dose bag. Advanced Ph...
Drugs·660 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
Midazolam 1 mg/mL (Midazolam HCL (USP) 55 mg, 0.9% Sodium Chloride, (USP) QS 55 mL) Volume: 55mL. Single dose syringe. Advanced Pharma, ...
Drugs·110 affected·Jun 12, 2018