January 17, 2018DrugsFDA
KRS Global Biotechnology, Inc recalls Human Chorionic Gonadotropin 20,000 iu/Vial, Lyophilized - For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Co
Hazard: 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.
January 17, 2018DrugsFDA
KRS Global Biotechnology, Inc recalls Human Chorionic Gonadotropin 11,000 iu/Vial Lyophilized For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Comme
Hazard: 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.
January 17, 2018DrugsFDA
KRS Global Biotechnology, Inc recalls Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized, Rx Only, KRS Global Biotechnology, 791 Park of Comm
Hazard: 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.
January 17, 2018DrugsFDA
KRS Global Biotechnology, Inc recalls Human Chorionic Gonadotropin 5,000 iu/ Vial Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Comm
Hazard: 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.
January 17, 2018DrugsFDA
KRS Global Biotechnology, Inc recalls Human Chorionic Gonadotropin 2,500 Units, Vial-Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of C
Hazard: 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.
January 17, 2018DrugsFDA
KRS Global Biotechnology, Inc recalls Human Chorionic Gonadotropin 500 iu Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of
Hazard: 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.
January 17, 2018DrugsFDA
KRS Global Biotechnology, Inc recalls Estriol 0.1% (1 mg/gm) Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton,
Hazard: 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.
January 17, 2018DrugsFDA
KRS Global Biotechnology, Inc recalls Chloramphenicol 500 mg Sulfamethoxazole 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx Only, KRS Global Biot
Hazard: 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.
January 17, 2018DrugsFDA
KRS Global Biotechnology, Inc recalls Chloramphenicol 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of C
Hazard: 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.
January 17, 2018DrugsFDA
KRS Global Biotechnology, Inc recalls Chloramphenicol 50 mg/ Sulfamethoxazole 50 mg/ Amphotericin-B 5 mg capsules, For OTIC Use Only, Rx Only, KRS Global Biot
Hazard: 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.
January 17, 2018DrugsFDA
KRS Global Biotechnology, Inc recalls Bi-Est (Estriol/Estradiol) (80/20) + Progesterone 7.5 mg/200 mg Cream packaged in jars, Rx Only, KRS Global Biotechnolog
Hazard: 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.
January 17, 2018DrugsFDA
KRS Global Biotechnology, Inc recalls Benzo/Lido/Tetracaine 20%-8%-8% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce
Hazard: 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.
January 17, 2018DrugsFDA
KRS Global Biotechnology, Inc recalls Benzocaine 20%, Lidocaine 8%, Tetracaine 4% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park
Hazard: 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.
January 17, 2018DrugsFDA
KRS Global Biotechnology, Inc recalls Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Comme
Hazard: 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.
January 17, 2018DrugsFDA
KRS Global Biotechnology, Inc recalls Arginine 150 mg/ Lysine HCl 50 mg/ Glutamine 200 mg/g Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology,
Hazard: 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.
January 17, 2018DrugsFDA
KRS Global Biotechnology, Inc recalls Anastrozole SR 1 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Hazard: 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.
January 17, 2018DrugsFDA
KRS Global Biotechnology, Inc recalls Amphotericin 60 mg/Chloramphenicol 600 mg/Hydrocortisone 10 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotech
Hazard: 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.
January 17, 2018DrugsFDA
KRS Global Biotechnology, Inc recalls Anastrozole 0.5 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Hazard: 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.
January 17, 2018DrugsFDA
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company recalls Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 32 oz. 12 units per box. Manufactured by Medex Ca
Hazard: Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
January 17, 2018DrugsFDA
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company recalls Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 16 oz. 12 units per box. Manufactured by Medex Ca
Hazard: Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
January 17, 2018DrugsFDA
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company recalls Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 4 oz. 24 units per box. Manufactured by Medex Car
Hazard: Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
January 17, 2018DrugsFDA
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company recalls Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. 144 units per box. Manufactured by Medex Ca
Hazard: Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
January 17, 2018DrugsFDA
SCA Pharmaceuticals recalls Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe, Total Volume 10 mL, Rx only, SCA Pharma
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date.
January 17, 2018DrugsFDA
Solco Healtcare US LLC recalls Gabapentin Tablets, USP, 800 mg, 500-count, Rx only, Made in India, PONDRUGS/16 134193, Distributed by: Solco Healthcare
Hazard: Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg
January 17, 2018DrugsFDA
ALLERGAN recalls Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by; Allergan USA Inc., Irvine,
Hazard: Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile.
January 17, 2018DrugsFDA
Sanofi-Aventis U.S. LLC recalls Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, Winthrop US., a business
Hazard: Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL
January 10, 2018DrugsFDA
Fresenius Kabi USA, LLC recalls Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton,
Hazard: Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL
January 10, 2018DrugsFDA
Pfizer Inc. recalls Zoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., NY, NY,
Hazard: SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
January 10, 2018DrugsFDA
Pfizer Inc. recalls diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg, a) 100-count bottle (NDC 59762-1061-1),
Hazard: SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
January 10, 2018DrugsFDA
Natures Supplement recalls Enhanced Vegetal Vigra 200 mg Capsules, 8 count bottles, Manufacturer: Hand-shaking (Int'l) Cop. USA, ADD: Hand-shaking
Hazard: Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with Sildenafil.