Home / Recalls / KRS Global Biotechnology, Inc / D-0051-2020

D-0051-2020 Class II Terminated

Recalled by KRS Global Biotechnology, Inc — Boca Raton, FL

FDA drug recall D-0051-2020 was initiated by KRS Global Biotechnology, Inc on September 12, 2019 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated August 19, 2021). Affected quantity: 1882 bags.

Recall Details

Product Type
Drugs
Report Date
October 9, 2019
Initiation Date
September 12, 2019
Termination Date
August 19, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1882 bags

Product Description

fentaNYL Citrate in 0.9% Sodium Chloride (PF) 2,500 mcg/100 mL (25 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487 NDC 33216286000

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide

Code Information

All lots remaining within expiry.

Other recalls by KRS Global Biotechnology, Inc

  • D-0071-2020 Class II — LIDOcaine 2% (20 mg/mL)/Bupivacaine 0.375% (3.75 mg/mL)/ Hyaluronidase 3 U/mL (P (September 12, 2019)
  • D-0110-2020 Class II — Vitamin 10 B Lyophilized, Vial, For IM Use, Rx Only, KRS Global Biotechnology 7 (September 12, 2019)
  • D-0118-2020 Class II — Isoproterenol HCL (PF) in D5W, 200 mcg / 50 mL (4 mcg/mL), 50 mL IV Bag, Single (September 12, 2019)
  • D-0090-2020 Class II — Polidocanol 5%, 500 mg / 10 mL (50 mg/mL), 10 mL Vial for IV Use, Rx Only, KRS G (September 12, 2019)
  • D-0039-2020 Class II — Alpha Lipoic Acid (PF) 750 mg/30 mL (25 mg/mL) 30 mL Single Dose Vial for IV Use (September 12, 2019)
  • D-0043-2020 Class II — Bimix #3 (Papaverine HCl 30 mg/mL/Phentolamine Mesylate 3 mg/mL) in 5 mL Vial, R (September 12, 2019)
  • D-0114-2020 Class II — Vitamin 9A/B Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 (September 12, 2019)
  • D-0069-2020 Class II — LIDOcaine HCl 2% (PF) 100 mg/5 mL (20 mg/mL) 5 mL Fill in a 6 mL Single Dose Syr (September 12, 2019)
  • D-0072-2020 Class II — Methionine 750 mg / Inositol 1,500 mg / Choline Chloride 1,500 mg / Pyridoxine H (September 12, 2019)
  • D-0053-2020 Class II — Glutathione 30 mL Vial-For IM Use-Hypertonic solution, 6,000 mg/30 mL (200 mg/mL (September 12, 2019)

FDA data resources