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D-1079-2019 Class II Terminated

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

FDA drug recall D-1079-2019 was initiated by KRS Global Biotechnology, Inc on January 16, 2019 and is designated Class II. Reason for recall: Labeling: Label mix-up The recall status is terminated (terminated February 4, 2021). Affected quantity: 433 250 mL bags.

Recall Details

Product Type: Drugs
Report Date: April 10, 2019
Initiation Date: January 16, 2019
Termination Date: February 4, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 433 250 mL bags

Product Description

NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF), 4 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321674481

Reason for Recall

Labeling: Label mix-up

Distribution Pattern

Nationwide in the USA

Code Information

Lot: 12122018@7 Exp. 02/10/2019

Other recalls by KRS Global Biotechnology, Inc

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-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-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-0110-2020 Class II — Vitamin 10 B Lyophilized, Vial, For IM Use, Rx Only, KRS Global Biotechnology 7 (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)