FDA recall D-0008-2018

Product

Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), Rx Only, For Injection, United Pharmacy Compounded, 13951 N. Haverhill Rd Ste. 120-121 West Palm Beach, FL 33417

Reason for recall

CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed

Distribution

Nationwide.

Key facts

Status

Terminated

Initiation date

2017-09-27

Report date

2017-10-18

Termination date

2018-03-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Palm Beach, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0008-2018