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.

26–50 of 129

SevereFDA (Drugs)·D-0094-2020·2019-10-09
KRS Global Biotechnology Recalls Sermorelin Acetate Injections Due to Sterility Concerns
KRS Global Biotechnology is recalling Sermorelin Acetate injections because the company cannot ensure the product is sterile. The recall covers 218 cartridges distributed nationwide.
Product
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 Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0113-2020·2019-10-09
KRS Global Biotechnology Recalls Vitamin 9 Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 470 vials of Vitamin 9 Lyophilized for IM use nationwide because the product lacks assurance of sterility.
Product
Vitamin 9 Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674147
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0088-2020·2019-10-09
KRS Global Biotechnology Recalls Phenylephrine IV Bags Due to Sterility Concerns
KRS Global Biotechnology is recalling 708 bags of Phenylephrine HCl IV infusion due to a lack of assurance of sterility.
Product
PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 25 mg / 250 mL (0.1 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677861
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0086-2020·2019-10-09
KRS Global Biotechnology Recalls Phenylephrine Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling 15,260 syringes of Phenylephrine HCl injection nationwide due to a lack of assurance of sterility.
Product
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, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677379
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0093-2020·2019-10-09
KRS Global Biotechnology Recalls Sermorelin Acetate Due to Sterility Concerns
KRS Global Biotechnology is recalling 258 vials of Sermorelin Acetate and GHRP-2 because the product lacks assurance of sterility.
Product
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 Raton, FL 33487. NDC 3321674047
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0114-2020·2019-10-09
KRS Global Biotechnology Recalls Vitamin 9A/B Lyophilized Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 6,325 vials of Vitamin 9A/B Lyophilized for IM use due to a lack of assurance of sterility.
Product
Vitamin 9A/B Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678339
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0075-2020·2019-10-09
KRS Global Biotechnology Recalls Moxifloxacin Ophthalmic Injection Due to Sterility Concerns
KRS Global Biotechnology is recalling 1,290 syringes of Moxifloxacin 0.1% ophthalmic injection nationwide due to a lack of assurance of sterility.
Product
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 Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678126
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0117-2020·2019-10-09
KRS Global Biotechnology Recalls L-Asparaginase Lyophilized Due to Sterility Concerns
KRS Global Biotechnology is recalling L-Asparaginase Lyophilized because the agency cannot assure the product's sterility. The recall covers all lots remaining within their expiration dates.
Product
L-Asparaginase Lyophilized, 10,000 International Units/Vial, For IV / IM / SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674499
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0055-2020·2019-10-09
KRS Global Biotechnology Recalls Glycopyrrolate Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling 2,625 syringes of Glycopyrrolate (PF) 1 mg/5 mL due to a lack of assurance of sterility.
Product
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 Blvd, Boca Raton, FL 33487. NDC03321678317
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0040-2020·2019-10-09
KRS Global Biotechnology Recalls Ascorbic Acid Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 2,219 vials of Ascorbic Acid (Tapioca Source) 25 g/50 mL due to a lack of assurance of sterility. The product is distributed nationwide.
Product
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 791 Park of Commerce Blvd, Boca Raton, FL 33487 NDC 3321675412
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0103-2020·2019-10-09
KRS Global Biotechnology Recalls Succinylcholine Chloride Syringes for Sterility Concerns
KRS Global Biotechnology is recalling 7,905 syringes of Succinylcholine Chloride (PF) due to a lack of assurance of sterility. The recall covers all lots remaining within expiry and is distributed nationwide.
Product
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 Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678418
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0107-2020·2019-10-09
KRS Global Biotechnology Recalls Ophthalmic Solution Due to Sterility Concerns
KRS Global Biotechnology is recalling Cyclopentolate HCl, Phenylephrine HCl, and Tropicamide ophthalmic solution because the company cannot guarantee the product is sterile.
Product
Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 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, FL 33487. NDC 3321678092
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0044-2020·2019-10-09
KRS Global Biotechnology Recalls L-Carnitine Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling L-Carnitine vials nationwide because the company cannot ensure the product is sterile.
Product
L-Carnitine 27 mL in a 30 mL Vial, 4,590 mg/27 mL (170 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674166
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0109-2020·2019-10-09
KRS Global Biotechnology Recalls Ophthalmic Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling 465 syringes of a sterile ophthalmic solution because the company cannot guarantee 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), 0.5 mL Fill in a 3 mL Syringe, Sterile Ophthalmic Topical Solution, (Contains Sulfites), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0083-2020·2019-10-09
KRS Global Biotechnology Recalls Oxytocin IV Bags Due to Sterility Concerns
KRS Global Biotechnology is recalling Oxytocin IV bags because the company cannot guarantee the product is sterile.
Product
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 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676819
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0082-2020·2019-10-09
KRS Global Biotechnology Recalls Norepinephrine IV Bags Due to Sterility Concerns
KRS Global Biotechnology is recalling 2,760 bags of Norepinephrine in 5% Dextrose IV solution due to a lack of assurance of sterility.
Product
Norepinephrine added to 5% Dextrose (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678217
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0052-2020·2019-10-09
KRS Global Fluorescein Vials Recalled for Sterility Assurance Issues
KRS Global Biotechnology is recalling Fluorescein vials because the company cannot guarantee the product is sterile.
Product
Fluorescein (PF) Lyophilized-For IV Use, Single Dose Vial, 500 mg/vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676632
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0118-2020·2019-10-09
KRS Global Biotechnology Recalls Isoproterenol HCL IV Bags Due to Sterility Concerns
KRS Global Biotechnology is recalling Isoproterenol HCL IV bags because the company cannot ensure the product is sterile.
Product
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, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677610
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0067-2020·2019-10-09
KRS Global Biotechnology Recalls Lidocaine and Epinephrine Syringes for Sterility Concerns
KRS Global Biotechnology is recalling 4,105 syringes of Lidocaine and Epinephrine due to a lack of assurance of sterility.
Product
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 only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678395
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0043-2020·2019-10-09
FDA Recalls Bimix #3 Vials Due to Lack of Sterility Assurance
KRS Global Biotechnology is recalling Bimix #3 vials because the company cannot ensure the product is sterile.
Product
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 Blvd, Boca Raton, FL 33487. NDC 3321676500
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0054-2020·2019-10-09
KRS Global Biotechnology Recalls Glycopyrrolate Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling Glycopyrrolate single-dose syringes nationwide because the company cannot guarantee the product is sterile.
Product
GLYCOpyrrolate (PF) 0.6 mg/3 mL (0.2 mg/mL) in 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321678316
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0058-2020·2019-10-09
KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Sterility Concerns
KRS Global Biotechnology is recalling 2,219 vials of Human Chorionic Gonadotropin 5,000 Units due to a lack of assurance of sterility. The recall is nationwide.
Product
Human Chorionic Gonadotropin 5,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC03321673964
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0068-2020·2019-10-09
KRS Global Biotechnology Recalls Lidocaine HCl Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling Lidocaine HCl 1% syringes because the company cannot guarantee the product is sterile.
Product
LIDOcaine HCl 1% (PF) 50 mg/5 mL (10 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 3321678424
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0099-2020·2019-10-09
Sermorelin Acetate Vials Recalled for Lack of Sterility Assurance
KRS Global Biotechnology is recalling Sermorelin Acetate vials due to a lack of assurance of sterility. The recall covers 341 vials distributed nationwide.
Product
Sermorelin Acetate 9 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673588
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0081-2020·2019-10-09
KRS Global Biotechnology Recalls Repinephrine IV Bags Due to Sterility Concerns
KRS Global Biotechnology is recalling 1,464 bags of Repinephrine in 0.9% Sodium Chloride due to a lack of assurance of sterility.
Product
NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678406
Category
Drug
Distribution
Distributed nationwide