Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
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.
KRS Global Biotechnology
Class I - Dangerous
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.
Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
KRS Global Biotechnology
Class I - Dangerous
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.
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.
KRS Global Biotechnology
Class I - Dangerous
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.
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.
KRS Global Biotechnology
Class I - Dangerous
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.
Progesterone 3% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
KRS Global Biotechnology
Class I - Dangerous
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.
QUADMIX #18, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
KRS Global Biotechnology
Class I - Dangerous
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.
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.
KRS Global Biotechnology
Class I - Dangerous
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.
Hydroquinone 8%/ Tretinoin 0.1% Topical Ointment packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
KRS Global Biotechnology
Class I - Dangerous
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.
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.
KRS Global Biotechnology
Class I - Dangerous
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.
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.
KRS Global Biotechnology
Class I - Dangerous
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.
Methylene Blue (PF) 10 mg/mL (1%) Injectable Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
KRS Global Biotechnology
Class I - Dangerous
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.
Vitamin 9 A/B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
KRS Global Biotechnology
Class I - Dangerous
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.
Class I - Dangerous
Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.
Anastrozole 0.5 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
KRS Global Biotechnology
Class I - Dangerous
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.
Liothyronine SR (T3) 20 mcg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd Boca Raton, FL 33487.
KRS Global Biotechnology
Class I - Dangerous
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.
QUADMIX #17, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
KRS Global Biotechnology
Class I - Dangerous
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.
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.
KRS Global Biotechnology
Class I - Dangerous
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.
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.
KRS Global Biotechnology
Class I - Dangerous
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.
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.
KRS Global Biotechnology
Class I - Dangerous
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.