The Recall Desk

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-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-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-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-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-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-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-0039-2020·2019-10-09

    KRS Global Biotechnology Recalls Alpha Lipoic Acid Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 77 vials of Alpha Lipoic Acid for IV use nationwide due to a lack of assurance of sterility.

    Product
    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 Blvd, Boca Raton, FL 33487. NDC 3321674205
    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
  • 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-0112-2020·2019-10-09

    KRS Global Biotechnology Recalls Vitamin 5 B Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 616 vials of Vitamin 5 B for IM use because the company cannot ensure the product is sterile.

    Product
    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0091-2020·2019-10-09

    KRS Global Biotechnology Recalls Quadmix #13A Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 91 vials of Quadmix #13A because the company cannot ensure the product is sterile.

    Product
    Quadmix #13A (Prostaglandin E1-0.3 mg / Papaverine HCl-200 mg / Phentolamine Mesylate-30 mg / Atropine Sulfate Monohydrate-0.375 mg / Vial) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678398
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0105-2020·2019-10-09

    FDA Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns

    KRS Global Biotechnology is recalling 3,820 syringes of Succinylcholine Chloride because the company cannot guarantee the product is sterile.

    Product
    SUCCinylcholine Chloride (PF), 200 mg/10 mL (20 mg/mL), 10 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 3321678416
    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-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-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-0080-2020·2019-10-09

    KRS Global Biotechnology Recalls Repinephrine IV Bags Due to Sterility Concerns

    KRS Global Biotechnology is recalling 528 bags of Repinephrine in 0.9% Sodium Chloride due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    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 Commerce Blvd, Boca Raton, FL 33487, NDC 3321678032
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0070-2020·2019-10-09

    KRS Global Biotechnology Recalls Lidocaine and Hyaluronidase Syringes for Sterility Concerns

    KRS Global Biotechnology is recalling Lidocaine HCl and Hyaluronidase syringes due to a lack of assurance of sterility. The recall covers 2,615 syringes distributed nationwide.

    Product
    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 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678368
    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-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-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, F
    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
  • SevereFDA (Drugs)·D-0090-2020·2019-10-09

    KRS Global Biotechnology Recalls Polidocanol Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 317 vials of Polidocanol 5% for IV use nationwide due to a lack of assurance of sterility.

    Product
    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, FL 33487. NDC 3321677749
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0108-2020·2019-10-09

    KRS Global Biotechnology Recalls Sterile Ophthalmic Solution Due to Sterility Concerns

    KRS Global Biotechnology is recalling 649 droptainers of a sterile ophthalmic solution because the company cannot ensure the product's sterility.

    Product
    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), 3 mL Droptainer, Sterile Ophthalmic Topical Solution, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3
    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-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