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.

26–47 of 47

  • ModerateFDA (Drugs)··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
    Distribution
    0 states
  • ModerateFDA (Drugs)··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
    Distribution
    0 states
  • ModerateFDA (Drugs)··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
    Distribution
    0 states
  • ModerateFDA (Drugs)··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
    Distribution
    0 states
  • ModerateFDA (Drugs)··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
    Distribution
    0 states
  • ModerateFDA (Drugs)··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
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-01-17

    KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Labeling Errors

    KRS Global Biotechnology is recalling 2,239 vials of Human Chorionic Gonadotropin because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-01-17

    FDA Recalls Bi-Est Cream Due to Expired Ingredient Dates

    KRS Global Biotechnology is recalling 300 jars of Bi-Est Cream because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Bi-Est (Estriol/Estradiol) (80/20) + Progesterone 7.5 mg/200 mg 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 Methylene Blue Injectable Vials for Labeling Errors

    KRS Global Biotechnology is recalling 696 vials of Methylene Blue (PF) 10 mg/mL Injectable due to incorrect or missing lot and expiration dates.

    Product
    Methylene Blue (PF) 10 mg/mL (1%) Injectable 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 Vitamin 9 A/B Lyophilized Vials Due to Labeling Errors

    KRS Global Biotechnology is recalling 3,612 vials of Vitamin 9 A/B Lyophilized Vials because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Vitamin 9 A/B Lyophilized 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 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
    Distribution
    0 states
  • ModerateFDA (Drugs)··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
    Distribution
    0 states
  • ModerateFDA (Drugs)··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
    Distribution
    0 states
  • ModerateFDA (Drugs)··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
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-01-17

    KRS Global Biotechnology Recalls Estriol Cream Due to Expired Ingredient

    KRS Global Biotechnology is recalling 300 jars of Estriol 0.1% Cream because the product's beyond-use date exceeds that of at least one ingredient.

    Product
    Estriol 0.1% (1 mg/gm) 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 Sermorelin Vials Due to Labeling Errors

    KRS Global Biotechnology is recalling 597 vials of Sermorelin and related peptides because the Beyond Use Date exceeds the expiration of at least one ingredient.

    Product
    Sermorelin, 3 mg/ GHRP6, 3 mg/GHRP2, 3 mg, 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 Human Chorionic Gonadotropin Vials for Labeling Errors

    KRS Global Biotechnology is recalling 2,274 vials of Human Chorionic Gonadotropin 20,000 iu due to incorrect or missing lot and expiration dates.

    Product
    Human Chorionic Gonadotropin 20,000 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 Recalls Human Chorionic Gonadotropin Tablets Due to Labeling Error

    KRS Global Biotechnology is recalling 2,239 Human Chorionic Gonadotropin tablets because the expiration date exceeds the shelf life of an ingredient.

    Product
    Human Chorionic Gonadotropin 500 iu 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 Trimix #23F Due to Incorrect Expiration Date

    KRS Global Biotechnology is recalling 94 vials of Trimix #23F because the product's expiration date exceeds the expiration date of at least one ingredient.

    Product
    Trimix #23F (Prostaglandin E1 6 mcg/ Papaverine HCl 17.8 mg/ Phentolamine Mesylate 0.6 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 Chloramphenicol and Amphotericin Otic Powder

    KRS Global Biotechnology is recalling 20 jars of Chloramphenicol and Amphotericin Otic Powder because the Beyond Use Date exceeds the expiration of at least one ingredient.

    Product
    Chloramphenicol 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

    FDA Recalls 7-Keto DHEA Capsules Due to Expired Ingredient

    KRS Global Biotechnology is recalling 7-Keto DHEA 100 mg capsules because the product's expiration date exceeds the expiration date of at least one ingredient.

    Product
    7-Ketodehydroepiandrosterone (7-Keto DHEA) 100 mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Distribution
    0 states