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FDAFDA · Food and drugs·Recall number D-0008-2018

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

Published October 18, 2017 · Recall initiated: September 27, 2017

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
United Pharmacy
Distributor
Nationwide.
Lot
Lot: GAC-12 BUD 11/10/17; Lot: GAC-13 BUD: 01/14/18
Risk classification
Class II
Area (FDA)
drug
Country
United States

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