Home / Recalls / KRS Global Biotechnology, Inc / D-0177-2018

D-0177-2018 Class II Terminated

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

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: 7,862 vials

Product Description

Human Chorionic Gonadotropin 11,000 iu/Vial Lyophilized For SC Use, 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

Lots: 06222017@10 BUD: 12/19/2017; 09272017@14 BUD: 3/26/2018; 05312017@5 BUD: 11/27/2017; 07192017@8 BUD: 1/15/2018

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-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-0111-2020 Class II — Vitamin 10 D Lyophilized, Vial For IM/Slow IV Infusion Use, Rx Only, KRS Global (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-0066-2020 Class II — Labetalol HCl 5 mg/mL 20 mg/4 mL (5 mg/mL) 4 mL Fill in a 6 mL Single Dose Syrin (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-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-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-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)