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
Krs Global Biotechnology, Inc
Isoproterenol HCL (PF) in D5W, 200 mcg / 50 mL (4 mcg/mL), 50 mL IV Bag, Single Dose Only, Contains Sulfites, For Slow IV use, Rx Only, ...
Injectable Drugs·0 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Phenylephrine HCl 1.5% (15 mg/mL) Lidocaine HCl 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL Single Dose Syringe, Rx Only...
Injectable Drugs·825 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 4 mg/250 mL (0.016 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Com...
Injectable Drugs·528 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Sodium Citrate 40 mg/mL (4%) / Gentamicin 0.32 mg/mL. 30 mL vial for Intra-Catheter Use Only, Rx Only, KRS Global Biotechnology 791 Park ...
Drugs·150 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Sodium Bicarbonate 8.4%, 4,200 mg / 50 mL 50 mEq / 50 mL (84 mg/mL) (1 mEq/mL), 50 mL Fill in a 60 mL Single Dose Syringe, For IV Use, Rx...
Injectable Drugs·540 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Bacteriostatic Water for Injection, 30 mL Vial, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 332...
Injectable Drugs·6,568 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Sermorelin Acetate 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487...
Drugs·64 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Labetalol HCl 5 mg/mL 20 mg/4 mL (5 mg/mL) 4 mL Fill in a 6 mL Single Dose Syringe, Rx only, KRS Global Biotechnology 791 Park of Commerc...
Drugs·6,405 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
LIDOcaine HCl 0.75%(7.5 mg/mL)/ EPINRPHrine 0.025% (0.25 mg/mL) (PF) (Sulfite Free) in BSS, 1 mL Fill in a 3 mL Single Dose Syringe, Rx o...
Drugs·4,105 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Hydroxocobalamin 10 mL Vial 5 mg/10 mL (0.5 mg/mL) For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, F...
Drugs·1,528 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 100 mg / 250 mL (0.4 mg/mL), 250 mL Single-Dose Bag For IV Infusion Us...
Injectable Drugs·228 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Polidocanol 5%, 500 mg / 10 mL (50 mg/mL), 10 mL Vial for IV Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton...
Injectable Drugs·317 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Methionine 750 mg / Inositol 1,500 mg / Choline Chloride 1,500 mg / Pyridoxine HCl 1,500 mg / Cyanocobalamin 30 mg Lyophilized, Vial For ...
Drugs·497 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Fluorescein (PF) Lyophilized-For IV Use, Single Dose Vial, 500 mg/vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca...
Injectable Drugs·1,980 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL),...
Topical Drugs·649 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Human Chorionic Gonadotropin 6,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Bo...
Drugs·2,263 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
fentaNYL Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg/100 mL (10 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnolo...
Injectable Drugs·492 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Hyaluronidase (PF) Ophthalmic Injection 450 Units/3 mL (150 Units/mL) 3 mL Fill in a 5 mL Single Dose Vial, Rx Only, KRS Global Biotechno...
Injectable Drugs·928 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Human Chorionic Gonadotropin 20,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Bo...
Drugs·1,871 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Use, 3 mL fill in a 5 mL Single Dose Vial, Rx Only, KRS Global...
Injectable Drugs·948 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
OxyTOCIN in 0.9% Sodium Chloride Solution (PF), 30 Units / 500 mL (0.06 Units / mL) Single Dose IV Bag, Rx Only, KRS Global Biotechnology...
Injectable Drugs·4,497 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
fentaNYL Citrate in 0.9% Sodium Chloride (PF) 2,500 mcg/100 mL (25 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnolog...
Injectable Drugs·1,882 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Hydroxocobalamin 10 mg/20 mL (0.5 mg/mL) 20 mL fill in a 30 mL Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Ra...
Drugs·345 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
fentaNYL Citrate in 0.9% Sodium Chloride (PF), 2,000 mcg/100 mL (20 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechno...
Injectable Drugs·934 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Nicotinamide Adenine Dinucleotide (PF), Lyophilized-For IV Use-Single Dose Vial, 500 mg/Vial, Rx Only, KRS Global Biotechnology 791 Park ...
Injectable Drugs·4,390 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Ketamine in 0.9% Sodium Chloride (PF) 10 mg/mL, 1 mL fill in a 3 mL Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd...
Drugs·1,044 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Bimix #3 (Papaverine HCl 30 mg/mL/Phentolamine Mesylate 3 mg/mL) in 5 mL Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blv...
Drugs·162 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.25 mg / 0.25 mL, 0.25 mL Fill in a 1 mL Single Dose Syringe, Rx Only, KRS Global Biotec...
Injectable Drugs·1,290 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
PHENYLephrine HCl 1.5% (15 mg/mL) LIDOcaine 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL fill in a 5 mL Single Dose Syrin...
Injectable Drugs·3,150 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Ascorbic Acid (Tapioca Source) (PF) 25 g/50 mL (0.5 g/mL) 50 mL Vial-Single Dose Only-For IV/SC/IM Use, Rx Only, KRS Global Biotechnology...
Injectable Drugs·2,219 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL), 0.5 mL Fill in a 3 mL Syrin...
Topical Drugs·465 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Vitamin 10 B Lyophilized, Vial, For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC332167...
Supplements·6,747 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 50 mg/10 mL (5 mg/mL) 10 mL Fill in a 12 mL Single Dose Syringe, Rx Only, KRS Global Biote...
Drugs·16,585 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
GLYCOpyrrolate (PF) 1 mg/5 mL (0.2 mg/mL) 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce...
Drugs·2,625 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Sermorelin, 3 mg/GHRP6, 3 mg/GHRP2, 3 mg/Vial, For SC Use, Vial-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd,...
Drugs·647 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Vitamin 5 B, 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674253
Supplements·616 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
SUCCinylcholine Chloride (PF), 100 mg / 5 mL (20 mg/mL), 5 mL Fill in a 6 mL Single Dose Syringe, For IV Use-Injection, Rx Only, KRS Glob...
Injectable Drugs·7,905 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
SUCCinylcholine Chloride (PF), 140 mg/7 mL (20 mg/mL), 7 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only, KRS Globa...
Injectable Drugs·1,350 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
ePHEDrine Sulfate in 0.9% Sodium Chloride (PF), 50 mg/5 mL (10 mg/mL) 5 mL Fill in a 6 mL Syringe, Single Dose Syringe. KRS Global Biote...
Drugs·3,895 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Sermorelin Acetate 9 mg/ 3 mL (3 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Drugs·152 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Sermorelin Acetate, 9 mg / GHRP-2, 5.4 mg/vial Lyophilized-for SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca ...
Drugs·258 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
LIDOcaine 2% (20 mg/mL)/Bupivacaine 0.375% (3.75 mg/mL)/ Hyaluronidase 3 U/mL (PF) Ophthalmic Injection, 5 mL Fill in a 6 mL Single Dose ...
Injectable Drugs·2,255 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.3 mg/0.3 mL, 0.3 mL Fill in a 1 mL Single Dose Syringe, Rx Only, KRS Global Biotechnolo...
Injectable Drugs·9,920 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
PHENYLephrine HCl in 0.9% Sodium Chloride (PF), 1 mg / 10 mL (0.1 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe Injection, Rx Only, K...
Injectable Drugs·15,260 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Sermorelin Acetate, 3 mg/mL/GHRP6, 1.8 mg/mL/GHRP2, 1.8 mg/mL, 3 mL Injections-CART-Item#: 73752, For SC Use, Rx Only, KRS Global Biotech...
Injectable Drugs·218 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Lidocaine HCl 30 mg/mL/Hyaluronidase 15 Units/mL (PF) 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Par...
Drugs·2,615 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Sermorelin Acetate 9 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487...
Drugs·341 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Alpha Lipoic Acid (PF) 750 mg/30 mL (25 mg/mL) 30 mL Single Dose Vial for IV Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce ...
Injectable Drugs·77 affected·Sep 12, 2019