Home / Recalls / KRS Global Biotechnology, Inc / D-0108-2020

D-0108-2020 Class II Terminated

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

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
649 droptainers

Product Description

Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL), 3 mL Droptainer, Sterile Ophthalmic Topical Solution, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676225

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-0041-2020 Class II — Ascorbic Acid (Tapioca Source) 25 g/50 mL (0.5 g/mL) 50 mL Vial--For SC/IM Use-C (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)
  • D-0111-2020 Class II — Vitamin 10 D Lyophilized, Vial For IM/Slow IV Infusion Use, Rx Only, KRS Global (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-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-0048-2020 Class II — ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 50 mg/10 mL (5 mg/mL) 10 mL Fill (September 12, 2019)
  • 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-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-0063-2020 Class II — Hydroxocobalamin 30 mg/30 mL (1 mg/mL) 30 mL Vial For IM Use, Rx Only, KRS Globa (September 12, 2019)