Glutamine recalled over manufacturing violations

Recall date

September 27, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

United Pharmacy recalls Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), Rx Only, For Injection, United Pharmacy Co…

Recall number

D-0008-2018

FDA classification

Class II

Brand / firm

United Pharmacy

Sold / distributed

Nationwide.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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