FDA recall D-0094-2020

KRS Global Biotechnology, Inc · Class II · drug

Product

Sermorelin Acetate, 3 mg/mL/GHRP6, 1.8 mg/mL/GHRP2, 1.8 mg/mL, 3 mL Injections-CART-Item#: 73752, For SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487.

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2019-09-12
Report date: 2019-10-09
Termination date: 2021-08-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Boca Raton, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0094-2020