Home / Recalls / KRS Global Biotechnology, Inc / D-0096-2020

D-0096-2020 Class II Terminated

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

FDA drug recall D-0096-2020 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: 246 vials.

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: 246 vials

Product Description

Sermorelin 9 mg / GHRP6, 5.4 mg / GHRP2, 5.4 mg, Vial For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673589

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-0096-2020
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

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

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D-0114-2020 Class II — Vitamin 9A/B Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791… (Sep 12, 2019)
D-0111-2020 Class II — Vitamin 10 D Lyophilized, Vial For IM/Slow IV Infusion Use, Rx Only, KRS Global… (Sep 12, 2019)
D-0117-2020 Class II — L-Asparaginase Lyophilized, 10,000 International Units/Vial, For IV / IM / SC… (Sep 12, 2019)
D-0053-2020 Class II — Glutathione 30 mL Vial-For IM Use-Hypertonic solution, 6,000 mg/30 mL (200… (Sep 12, 2019)