The Recall Desk

FDA (Drugs) recall action 78553

KRS Global Biotechnology, Inc recalled 47 products on 2018-01-17

The FDA (Drugs) publishes a recall like this one as 47 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 47 pages.

Products
47
Announced
2018-01-17
Critical
0
Units
97,236

Why these products were recalled

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–25 of 47

  • ModerateFDA (Drugs)··2018-01-17

    KRS Global Biotechnology Recalls Sincalide Vials Due to Labeling Errors

    KRS Global Biotechnology is recalling 898 vials of Sincalide 5 mcg due to incorrect or missing lot and expiration dates.

    Product
    Sincalide 5 mcg Lyophilized Vials, For IV Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-01-17

    KRS Global Biotechnology Recalls Prednisolone Tablets Due to Labeling Errors

    KRS Global Biotechnology is recalling 3,000 Prednisolone 10 mg tablets because the expiration date exceeds the stability of an ingredient.

    Product
    PrednisoLONE 10 mg Tablet, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-01-17

    KRS Global Biotechnology Recalls Trimix #22F Due to Labeling Errors

    KRS Global Biotechnology is recalling 235 vials of Trimix #22F because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Trimix #22F (Prostaglandin E1 25 mcg/ Papaverine HCl 30 mg/ Phentolamine Mesylate 2 mg/mL), For Intracavernous Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-01-17

    KRS Global Biotechnology Recalls QUADMIX #18 Vials Due to Labeling Errors

    KRS Global Biotechnology is recalling 129 vials of QUADMIX #18 because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    QUADMIX #18, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-01-17

    KRS Global Biotechnology Recalls Sermorelin Tablets Due to Labeling Errors

    KRS Global Biotechnology is recalling Sermorelin 500 mcg tablets because the expiration date exceeds the shelf life of an ingredient.

    Product
    Sermorelin 500 mcg Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-01-17

    KRS Global Biotechnology Recalls Topical Cream Due to Expired Ingredients

    KRS Global Biotechnology is recalling 1,380 jars of Benzocaine, Lidocaine, and Tetracaine Topical Cream because the product's beyond-use date exceeds the expiration dates of its ingredients.

    Product
    Benzocaine 20%, Lidocaine 8%, Tetracaine 4% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-01-17

    KRS Global Biotechnology Recalls Iodochlorhydroxyquin Otic Powder Due to Labeling Error

    KRS Global Biotechnology is recalling 40 jars of Iodochlorhydroxyquin Otic Powder because the Beyond Use Date exceeds the expiration of at least one ingredient.

    Product
    Iodochlorhydroxyquin 3%/ Boric Acid 10%/ Amphotericin 5% Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-01-17

    KRS Global Biotechnology Recalls Ophthalmic Solution Due to Labeling Errors

    KRS Global Biotechnology is recalling 297 droptainers of a multi-ingredient ophthalmic solution because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 2.5%/ 1%/ 0.5% Ophthalmic Solution, 3 mL Multi Dose Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-01-17

    KRS Global Biotechnology Recalls Benzo/Lido/Tetracaine Topical Cream Due to Labeling Errors

    KRS Global Biotechnology is recalling 3,280 jars of Benzo/Lido/Tetracaine 20%-8%-8% Topical Cream because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Benzo/Lido/Tetracaine 20%-8%-8% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-01-17

    KRS Global Biotechnology Recalls Topical Cream Due to Expired Ingredient

    KRS Global Biotechnology is recalling 490 jars of Arginine/Lysine/Glutamine Topical Cream because the product's Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Arginine 150 mg/ Lysine HCl 50 mg/ Glutamine 200 mg/g Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd Boca Raton, FL 33487.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-01-17

    KRS Global Biotechnology Recalls Chloramphenicol Otic Powder Due to Labeling Errors

    KRS Global Biotechnology is recalling 100 jars of Chloramphenicol Otic Powder because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Chloramphenicol 500 mg Sulfamethoxazole 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-01-17

    KRS Global Biotechnology Recalls Sermorelin Cartridges Due to Labeling Errors

    KRS Global Biotechnology is recalling 80 Sermorelin cartridges because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Sermorelin, 3 mg/ GHRP6, 1.8 mg/ GHRP2, 1.8 mg/mL in 3 mL Cartridge, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-01-17

    KRS Global Biotechnology Recalls Amphotericin Otic Powder Due to Labeling Error

    KRS Global Biotechnology is recalling 80 vials of Amphotericin Otic Powder because the Beyond Use Date exceeds the expiration of at least one ingredient.

    Product
    Amphotericin 60 mg/Chloramphenicol 600 mg/Hydrocortisone 10 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-01-17

    KRS Global Biotechnology Recalls T-105 Vials Due to Expired Ingredient Dates

    KRS Global Biotechnology is recalling 173 vials of T-105 because the Beyond Use Date exceeds the expiration of at least one ingredient.

    Product
    T-105 (Prostaglandin E1, 10 mcg/ Papaverine 30 mg/ Phentolamine 1 mg/mL), For Intracavernouse Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-01-17

    KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Labeling Errors

    KRS Global Biotechnology is recalling 7,862 vials of Human Chorionic Gonadotropin because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Human Chorionic Gonadotropin 11,000 iu/Vial Lyophilized For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-01-17

    KRS Global Biotechnology Recalls Hydroxocobalamin Vials Due to Labeling Errors

    KRS Global Biotechnology is recalling 596 vials of Hydroxocobalamin 1 mg/mL due to incorrect or missing lot and expiration dates.

    Product
    Hydroxocobalamin 1 mg/mL 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-01-17

    KRS Global Biotechnology Recalls Progesterone 3% Topical Cream Due to Labeling Errors

    KRS Global Biotechnology is recalling 300 jars of Progesterone 3% Topical Cream because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Progesterone 3% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-01-17

    KRS Global Biotechnology Recalls Anastrozole SR Capsules Due to Labeling Errors

    KRS Global Biotechnology is recalling Anastrozole SR 1 mg capsules because the Beyond Use Dates exceed the expiration dates of some ingredients.

    Product
    Anastrozole SR 1 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··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
    Distribution
    0 states
  • ModerateFDA (Drugs)··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
    Distribution
    0 states
  • ModerateFDA (Drugs)··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
    Distribution
    0 states
  • ModerateFDA (Drugs)··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
    Distribution
    0 states
  • ModerateFDA (Drugs)··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
    Distribution
    0 states
  • ModerateFDA (Drugs)··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
    Distribution
    0 states
  • ModerateFDA (Drugs)··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
    Distribution
    0 states