Home / Recalls / KRS Global Biotechnology, Inc / D-0198-2018

D-0198-2018 Class II Terminated

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

FDA drug recall D-0198-2018 was initiated by KRS Global Biotechnology, Inc on November 16, 2017 and is designated Class II. Reason for recall: 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 recall status is terminated (terminated May 11, 2020). Affected quantity: 235 vials.

Recall Details

Product Type
Drugs
Report Date
January 17, 2018
Initiation Date
November 16, 2017
Termination Date
May 11, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
235 vials

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Nationwide in the USA, Bermuda, and New Zealand

Code Information

Lot: 05262017@21 BUD: 11/22/2017; 07132017@2 BUD: 1/9/2018

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