FDA recall D-1256-2019

Customceutical Compounding · Class II · drug

Product

HCG (CHORIONIC GONADOTROPIN 1000 IU/ML PEP 25 mg/mL) inj 5 mL multidose vial compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272

Reason for recall

Lack of assurance of sterility for injectables and solutions intended to be sterile.

Distribution

U.S.A. Nationwide

Key facts

Status: Terminated
Initiation date: 2019-04-08
Report date: 2019-05-08
Termination date: 2023-05-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Phoenix, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1256-2019