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.

76–100 of 129

  • 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-0062-2020·2019-10-09

    KRS Global Biotechnology Recalls Hydroxocobalamin Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 345 vials of Hydroxocobalamin 10 mg/20 mL due to a lack of assurance of sterility. The recall covers all lots remaining within expiry and is distributed nationwide.

    Product
    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 Raton, FL 33487. NDC 3321678337
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0053-2020·2019-10-09

    KRS Global Biotechnology Recalls Glutathione Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 402 vials of Glutathione 30 mL due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Glutathione 30 mL Vial-For IM Use-Hypertonic solution, 6,000 mg/30 mL (200 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321674186
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0100-2020·2019-10-09

    Sermorelin and GHRP-2 Lyophilized Vials Recalled Due to Sterility Concerns

    KRS Global Biotechnology is recalling 120 vials of Sermorelin and GHRP-2 because the company cannot assure the products are sterile.

    Product
    Sermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674092
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0066-2020·2019-10-09

    Labetalol HCl syringes are recalled due to lack of sterility assurance

    The FDA is recalling 6,405 units of Labetalol HCl single-dose syringes because there was insufficient assurance of sterility during production. No illnesses or injuries have been reported.

    Product
    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 Commerce Blvd, Boca Raton, FL 33487. NDC 3321676419
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1079-2019·2019-04-10

    KRS Global Biotechnology Recalls NORepinephrine IV Bags Due to Labeling Error

    KRS Global Biotechnology is recalling 433 bags of NORepinephrine 4 mg in 5% Dextrose due to a label mix-up. The product was distributed nationwide.

    Product
    NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF), 4 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321674481
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1078-2019·2019-04-10

    KRS Global Biotechnology Recalls Repinephrine IV Bags Due to Labeling Error

    KRS Global Biotechnology is recalling 190 bags of Repinephrine 16 mg IV solution due to a label mix-up. The product was distributed nationwide.

    Product
    NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321678343
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0161-2018·2018-01-17

    KRS Global Biotechnology Recalls Anastrozole 0.5 mg Capsules for Labeling Errors

    KRS Global Biotechnology is recalling 15,700 capsules of Anastrozole 0.5 mg due to incorrect or missing lot and expiration dates.

    Product
    Anastrozole 0.5 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0165-2018·2018-01-17

    KRS Global Biotechnology Recalls Benzocaine Cream Due to Labeling Errors

    KRS Global Biotechnology is recalling 4,530 jars of Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0190-2018·2018-01-17

    KRS Global Biotechnology Recalls QUADMIX #17 Due to Expired Ingredients

    KRS Global Biotechnology is recalling 122 vials of QUADMIX #17 because the product's beyond-use date exceeds the expiration date of at least one ingredient.

    Product
    QUADMIX #17, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0180-2018·2018-01-17

    KRS Global Biotechnology Recalls Hydroxocobalamin Vials Due to Labeling Errors

    KRS Global Biotechnology is recalling 1,009 vials of Hydroxocobalamin 0.5 mg/mL because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Hydroxocobalamin 0.5 mg/mL For Diluent Purpose Only 10 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0169-2018·2018-01-17

    KRS Global Biotechnology Recalls Chloramphenicol Otic Capsules Due to Labeling Errors

    KRS Global Biotechnology is recalling Chloramphenicol 50 mg/Sulfamethoxazole 50 mg/Amphotericin-B 5 mg capsules because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Chloramphenicol 50 mg/ Sulfamethoxazole 50 mg/ Amphotericin-B 5 mg capsules, For OTIC Use Only, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0202-2018·2018-01-17

    KRS Global Biotechnology Recalls Ophthalmic Solution Due to Labeling Errors

    KRS Global Biotechnology is recalling 81 droptainers of a multi-dose ophthalmic solution because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 10%/ 1%/ 0.5% Ophthalmic Soln, 5 mL Multi Dose Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0186-2018·2018-01-17

    KRS Global Biotechnology Recalls Oxytocin IV Bags Due to Labeling Errors

    KRS Global Biotechnology is recalling 963 bags of Oxytocin 30 Units IV solution because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Oxytocin 30 Units in 0.9% Sodium Chloride Solution (PF) IV Bag, For IV Infusion Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0205-2018·2018-01-17

    KRS Global Biotechnology Recalls Vitamin 10 B Vials Due to Labeling Errors

    KRS Global Biotechnology is recalling 5,786 vials of Vitamin 10 B Lyophilized Vial due to incorrect or missing lot and expiration dates.

    Product
    Vitamin 10 B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0207-2018·2018-01-17

    KRS Global Biotechnology Recalls 7-Keto DHEA Capsules Due to Labeling Error

    KRS Global Biotechnology is recalling 7-Keto DHEA 25mg capsules because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    7-Keto DHEA 25mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0175-2018·2018-01-17

    KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Labeling Errors

    KRS Global Biotechnology is recalling 6,414 vials of Human Chorionic Gonadotropin because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Human Chorionic Gonadotropin 5,000 iu/ Vial Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0189-2018·2018-01-17

    KRS Global Biotechnology Recalls QUADMIX #16 Due to Labeling Errors

    KRS Global Biotechnology is recalling 126 vials of QUADMIX #16 because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    QUADMIX #16, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0174-2018·2018-01-17

    KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Vials for Labeling Errors

    KRS Global Biotechnology is recalling 1,203 vials of Human Chorionic Gonadotropin due to incorrect or missing lot and expiration dates.

    Product
    Human Chorionic Gonadotropin 2,500 Units, Vial-Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0192-2018·2018-01-17

    FDA Recalls Savinase Topical Solution Due to Expired Ingredient Labeling

    KRS Global Biotechnology is recalling Savinase 100 mcg/mL Topical Solution because the product's beyond-use date exceeds the expiration date of at least one ingredient.

    Product
    Savinase 100 mcg/mL Topical Solution, 1 mL in a 3 mL Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0183-2018·2018-01-17

    KRS Global Biotechnology Recalls Liothyronine SR Capsules Due to Labeling Errors

    KRS Global Biotechnology is recalling Liothyronine SR 20 mcg capsules because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Liothyronine SR (T3) 20 mcg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0185-2018·2018-01-17

    FDA Recalls Nicotinamide Adenine Dinucleotide Vials Due to Labeling Errors

    KRS Global Biotechnology is recalling 2,535 vials of Nicotinamide Adenine Dinucleotide 500 mg because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Nicotinamide Adenine Dinucleotide 500 mg packaged in vials, Lyophilized-For IV Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0179-2018·2018-01-17

    KRS Global Biotechnology Recalls Hydroquinone and Tretinoin Ointment Jars

    KRS Global Biotechnology is recalling 30 jars of Hydroquinone 8%/Tretinoin 0.1% Topical Ointment because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Hydroquinone 8%/ Tretinoin 0.1% Topical Ointment packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0203-2018·2018-01-17

    KRS Global Biotechnology Recalls Vitamin 9 Vials Due to Labeling Errors

    KRS Global Biotechnology is recalling 479 vials of Vitamin 9 Lyophilized Vial due to incorrect or missing lot and expiration dates.

    Product
    Vitamin 9 Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0196-2018·2018-01-17

    KRS Global Biotechnology Recalls Sermorelin Acetate Vials Due to Labeling Errors

    KRS Global Biotechnology is recalling 157 vials of Sermorelin Acetate/GHRP6 due to incorrect or missing lot and expiration dates.

    Product
    Sermorelin Acetate 3 mg/ GHRP6 3 mg, Lyophilized Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide