Home / Recalls / KRS Global Biotechnology, Inc / D-0049-2020

D-0049-2020 Class II Terminated

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

FDA drug recall D-0049-2020 was initiated by KRS Global Biotechnology, Inc on Sep 12, 2019 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated Aug 19, 2021). Affected quantity: 492 bags.

Recall Details

Product Type: Drugs
Report Date: Oct 9, 2019
Initiation Date: Sep 12, 2019
Termination Date: Aug 19, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 492 bags

Product Description

fentaNYL Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg/100 mL (10 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 33216282300

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide

Code Information

All lots remaining within expiry.

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0049-2020
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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… (Sep 12, 2019)
D-0043-2020 Class II — Bimix #3 (Papaverine HCl 30 mg/mL/Phentolamine Mesylate 3 mg/mL) in 5 mL Vial… (Sep 12, 2019)
D-0045-2020 Class II — L-Carnitine 27 mL Fill in a 30 mL Vial, For Dilution Use Only, 2,025 mg/27 mL… (Sep 12, 2019)
D-0110-2020 Class II — Vitamin 10 B Lyophilized, Vial, For IM Use, Rx Only, KRS Global Biotechnology… (Sep 12, 2019)
D-0113-2020 Class II — Vitamin 9 Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791… (Sep 12, 2019)
D-0062-2020 Class II — Hydroxocobalamin 10 mg/20 mL (0.5 mg/mL) 20 mL fill in a 30 mL Vial, Rx Only… (Sep 12, 2019)
D-0044-2020 Class II — L-Carnitine 27 mL in a 30 mL Vial, 4,590 mg/27 mL (170 mg/mL) Rx Only, KRS… (Sep 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… (Sep 12, 2019)
D-0051-2020 Class II — fentaNYL Citrate in 0.9% Sodium Chloride (PF) 2,500 mcg/100 mL (25 mcg/mL) 100… (Sep 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… (Sep 12, 2019)