Manufacturer

KRS Global Biotechnology, Inc

129 recalls in our database name KRS Global Biotechnology, Inc as the manufacturing or recalling firm.

What the numbers show

Total: 129
Critical: 0
Severe: 73
Most recent: 2019-10-09

Of the 129 recalls from KRS Global Biotechnology, Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 73 (57%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–75 of 129

SevereFDA (Drugs)·D-0106-2020·2019-10-09
KRS Global Biotechnology Recalls Sterile Ophthalmic Solution Due to Sterility Concerns
KRS Global Biotechnology is recalling 1,815 syringes of a sterile ophthalmic topical solution because the company cannot assure the product's sterility.
Product
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) / Ketorolac Tromethamine 0.5% (2.5 mg/0.5 mL), Sterile Ophthalmic Topical Solution, 0.5 mL Fill in 3 mL Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0115-2020·2019-10-09
KRS Global Biotechnology Recalls IV Vitamin B12 Vials for Sterility Concerns
KRS Global Biotechnology is recalling 948 vials of IV Vitamin B12 products due to a lack of assurance of sterility. The recall is nationwide.
Product
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 Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678335
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0074-2020·2019-10-09
KRS Global Biotechnology Recalls IV Magnesium and Calcium Vials for Sterility Concerns
KRS Global Biotechnology is recalling 878 vials of IV magnesium and calcium solution due to a lack of assurance of sterility.
Product
Magnesium Chloride Hexahydrate 82.5 mg/mL; Calcium Gluconate 30 mg/mL (PF), For IV Use, 10 mL Single Dose vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678355
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0102-2020·2019-10-09
KRS Global Biotechnology Recalls Sodium Citrate and Gentamicin Vials
KRS Global Biotechnology is recalling 150 vials of Sodium Citrate and Gentamicin solution due to a lack of assurance of sterility.
Product
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 of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676603
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0048-2020·2019-10-09
KRS Global Biotechnology Recalls ePHEDrine Sulfate Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling ePHEDrine Sulfate syringes nationwide because the company cannot guarantee the product is sterile.
Product
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 Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678373
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0069-2020·2019-10-09
KRS Global Biotechnology Recalls Lidocaine HCl Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling Lidocaine HCl 2% syringes nationwide due to a lack of assurance of sterility. The recall affects 4,450 syringes.
Product
LIDOcaine HCl 2% (PF) 100 mg/5 mL (20 mg/mL) 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487NDC 3321678315
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0061-2020·2019-10-09
KRS Global Biotechnology Recalls Hydroxocobalamin Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling Hydroxocobalamin 10 mL vials because the company cannot ensure the product is sterile. The recall covers 1,528 units distributed nationwide.
Product
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, FL 33487. NDC 3321678336
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0077-2020·2019-10-09
KRS Global Biotechnology Recalls Neostigmine Methylsulfate Syringes for Sterility Concerns
KRS Global Biotechnology is recalling 7,685 vials of Neostigmine Methylsulfate due to a lack of assurance of sterility. The recall is nationwide.
Product
NEOstigmine Methylsulfate (PF), 3 mg/3 mL (1 mg/mL), 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677847
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0057-2020·2019-10-09
KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Sterility Concerns
KRS Global Biotechnology is recalling 1,871 vials of Human Chorionic Gonadotropin 20,000 Units due to a lack of assurance of sterility.
Product
Human Chorionic Gonadotropin 20,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673977
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0042-2020·2019-10-09
KRS Global Biotechnology Recalls Bacteriostatic Water for Injection Due to Sterility Concerns
KRS Global Biotechnology is recalling Bacteriostatic Water for Injection vials because the product lacks assurance of sterility.
Product
Bacteriostatic Water for Injection, 30 mL Vial, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674177
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0059-2020·2019-10-09
KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Sterility Concerns
KRS Global Biotechnology is recalling 2,263 vials of Human Chorionic Gonadotropin 6,000 Units due to a lack of assurance of sterility.
Product
Human Chorionic Gonadotropin 6,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673969
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0049-2020·2019-10-09
FDA Recalls Fentanyl IV Bags Due to Sterility Concerns
KRS Global Biotechnology is recalling 492 bags of fentanyl IV solution nationwide due to a lack of assurance of sterility.
Product
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 Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216282300
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0097-2020·2019-10-09
KRS Global Biotechnology Recalls Sermorelin Acetate Due to Sterility Concerns
KRS Global Biotechnology is recalling 152 cartridges of Sermorelin Acetate 9 mg/3 mL nationwide due to a lack of assurance of sterility.
Product
Sermorelin Acetate 9 mg/ 3 mL (3 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0078-2020·2019-10-09
KRS Global Biotechnology Recalls Neostigmine Methylsulfate Syringes for Sterility Concerns
KRS Global Biotechnology is recalling Neostigmine Methylsulfate syringes due to a lack of assurance of sterility. The recall covers 3,410 syringes distributed nationwide.
Product
NEOstigmine Methylsulfate (PF), 5 mg/5 mL (1 mg/mL), 5 mL fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678303
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0101-2020·2019-10-09
Sodium Bicarbonate Syringes Recalled for Lack of Sterility Assurance
KRS Global Biotechnology is recalling 540 syringes of Sodium Bicarbonate 8.4% for IV use due to a lack of assurance of sterility.
Product
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 Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674199
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0047-2020·2019-10-09
KRS Global Biotechnology Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling ephedrine sulfate syringes nationwide because the company cannot guarantee the product is sterile.
Product
ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 25 mg/5 mL (5 mg/mL) 5 mL Fill in a 6 mL Syringe, Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678374
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0116-2020·2019-10-09
KRS Global Biotechnology Recalls Sterile Ophthalmic Solution Due to Sterility Concerns
KRS Global Biotechnology is recalling 242 droptainers of a sterile ophthalmic solution because the company cannot guarantee the product's sterility.
Product
Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 10% (100 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL), Sterile Ophthalmic Topical Solution, 5 mL Fill in a 7 mL Droptainer,Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0111-2020·2019-10-09
KRS Global Biotechnology Recalls Vitamin D Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 508 vials of Vitamin 10 D Lyophilized due to a lack of assurance of sterility. The product is distributed nationwide.
Product
Vitamin 10 D Lyophilized, Vial For IM/Slow IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678341
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0092-2020·2019-10-09
KRS Global Biotechnology Recalls Quadmix # 19 Due to Sterility Concerns
KRS Global Biotechnology is recalling 95 vials of Quadmix # 19 because the company cannot ensure the product is sterile.
Product
Quadmix # 19 (Prostaglandin E1-0.75 mg / Papaverine HCl-150 mg / Phentolamine Mesylate-15 mg / Atropine Sulfate Monohydrate-1.5 mg/vial), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678383
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0096-2020·2019-10-09
KRS Global Biotechnology Recalls Sermorelin Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling Sermorelin vials because the company cannot guarantee the product is sterile. Consumers should stop using the medication and contact their healthcare provider.
Product
Sermorelin 9 mg / GHRP6, 5.4 mg / GHRP2, 5.4 mg, Vial For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673589
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0084-2020·2019-10-09
KRS Global Biotechnology Recalls Phenylephrine and Lidocaine Ophthalmic Injection
KRS Global Biotechnology is recalling 825 syringes of Phenylephrine and Lidocaine Ophthalmic Injection due to a lack of assurance of sterility.
Product
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, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678441
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0098-2020·2019-10-09
KRS Global Biotechnology Recalls Sermorelin Acetate Due to Sterility Concerns
KRS Global Biotechnology is recalling Sermorelin Acetate 3 mg vials because the company cannot ensure the product is sterile.
Product
Sermorelin Acetate 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321601122
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0104-2020·2019-10-09
FDA Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling 1,350 syringes of Succinylcholine Chloride (PF) because the company cannot ensure the product is sterile.
Product
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 Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678417
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0056-2020·2019-10-09
KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Sterility Concerns
KRS Global Biotechnology is recalling 6,620 vials of Human Chorionic Gonadotropin 11,000 Units due to a lack of assurance of sterility.
Product
Human Chorionic Gonadotropin 11,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673974
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0110-2020·2019-10-09
KRS Global Biotechnology Recalls Vitamin 10 B Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 6,747 vials of Vitamin 10 B Lyophilized for IM use nationwide due to a lack of assurance of sterility.
Product
Vitamin 10 B Lyophilized, Vial, For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321678338
Category
Drug
Distribution
Distributed nationwide